Fluid management system

ABSTRACT

Fluid management system and method of operating a fluid management system which may provide one or more functions associated with suction, irrigation, distention, deficit monitoring, infusion, fluid warming, and the like. The fluid management system may be selectable between pressure control and flow control modes.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/798,414, filed Mar. 13, 2013, which is a continuation-in-part (CIP)of U.S. application Ser. No. 12/720,475, filed Mar. 9, 2010 (now U.S.Pat. No. 8,444,592, issued May 21, 2013), which claims the benefit ofU.S. Provisional Application No. 61/158,574, filed Mar. 9, 2009, saidpatent applications herein fully incorporated by reference.

This application is related to U.S. application Ser. No. 12/720,488,filed Mar. 9, 2010 (now U.S. Pat. No. 8,790,303, issued Jul. 29, 2014),Ser. No. 12/720,496, filed Mar. 9, 2010 (now U.S. Pat. No. 8,597,228,issued Dec. 3, 2013, and Ser. No. 13/887,583, filed May 6, 2013 (nowU.S. Pat. No. 9,272,086, issued Mar. 1, 2016), and U.S. Design Pat.application No. 29/357,184, filed Mar. 8, 2010 (now U.S. Design Pat. No.D657,865).

BACKGROUND OF THE INVENTION

The present invention is directed to fluid management systems and, moreparticularly, to fluid management systems providing one or morefunctions associated with suction, irrigation, distention, deficitmonitoring, infusion, fluid warming, and the like.

SUMMARY OF THE INVENTION

Exemplary embodiments may include surgical fluid management systems andmethods of operating surgical fluid management systems, which mayprovide one or more functions associated with suction, irrigation,distention, deficit monitoring, infusion, fluid warming, and the like.Some example embodiments may include infrared lamps arranged to warmfluid flowing through a disposable cartridge. Some example embodimentsmay provide a three-dimensional fluid path through the cartridge and/ormulti-stage heating capabilities. Some example fluid management systemsmay be selectable between pressure control and flow control modes.

In an aspect, a surgical fluid management system may include a pumpconfigured to deliver a fluid to a surgical site; and a control system,the control system being user-selectable between a pressure control modeand a flow control mode. The pressure control mode may includecontrolling the pump to deliver the fluid to the surgical site atapproximately a target pressure, and the flow control mode may includecontrolling the pump to deliver the fluid to the surgical site atapproximately a target flow rate.

In a detailed embodiment, a surgical fluid management system may includeat least one pressure sensor configured to generate a pressure signalassociated with a pressure of the fluid and/or the control system may beconfigured to control the pump in the pressure control mode based atleast in part upon the pressure signal. In a detailed embodiment, the atleast one pressure sensor may include at least a first pressure sensorand a second pressure sensor, the first pressure sensor and the secondpressure being configured to generate respective pressure signalsassociated with the pressure of the fluid. In a detailed embodiment, thecontrol system may be configured to compare the first pressure signaland the second pressure signal and/or may be configured such that if thefirst pressure signal and the second pressure signal differ by an amountin excess of an acceptable tolerance band, the control system mayautomatically stop the pump.

In a detailed embodiment, the pump may include a positive displacementpump, a fluid flow rate through the pump may be substantially directlyrelated to a speed of operation of the pump, and/or the control systemmay be configured to control the pump in the flow control mode based atleast in part upon a flow rate calculated based upon the speed of thepump.

In a detailed embodiment, a surgical fluid management system may includea heater assembly configured to heat the fluid between a fluid supplycontainer and the surgical site. In a detailed embodiment, a surgicalfluid management system may include a touch screen interface configuredto display at least one operating parameter and to receive at least onecommand, and the control system may be selectable between the pressurecontrol mode and the flow control mode using the touch screen. In adetailed embodiment, the touch screen may be configurable with respectto at least one of content and layout.

In an aspect, a surgical fluid management device may include a pumpconfigured to propel fluid from a fluid supply container to a surgicalsite; a heater assembly configured to heat the fluid as it is propelledfrom the fluid source to the surgical site; and a control systemoperatively connected to the pump and the heater assembly. The controlsystem may be configured to control the pump and the heater assembly inat least a distention mode and an irrigation mode, the distention modemay include operation of the pump to maintain a fluid pressure within apredetermined pressure band, the irrigation mode may include operationof the pump to provide a fluid flow rate within a predetermined flowrate band, and/or the control system may be configured to control theheater to maintain a temperature of the fluid delivered to the surgicalsite within a predetermined temperature band in at least the distentionmode and/or the irrigation mode.

In a detailed embodiment, the distention mode may include calculation ofa fluid deficit associated with a difference between a volume of fluiddelivered to the surgical site and a volume of fluid returned from thesurgical site. In a detailed embodiment, a surgical fluid managementdevice may include at least one load cell configured to generate anelectrical signal associated with a weight of a fluid supply containerand/or at least one load cell configured to generate an electricalsignal associated with a weight of a fluid collection container. Thecontrol system may be operative to calculate a difference between aninitial total system weight including an initial weight of the fluidsupply container and an initial weight of the fluid collection containerand current total system weight including the current weight of thefluid supply container and the current weight of the fluid collectioncontainer.

In a detailed embodiment, the control system may be operative to controlthe pump and the heater in an infusion mode. The infusion mode mayinclude operating the pump to infuse the fluid at a desired flow ratewhile monitoring at least one bubble detector, the bubble detector beingoperatively connected to the control system such that detection of abubble results in stopping the pump.

In a detailed embodiment, a surgical fluid management device may includea tubing and cartridge set including a cartridge configured to bereceived within the heater assembly, the cartridge including an internalfluid path, a first section of tubing extending at least partway fromthe source of fluid to the cartridge, and a second section of tubingextending from the cartridge at least partway to the surgical site.

In a detailed embodiment, the pump may include a positive displacementpump. In a detailed embodiment, the positive displacement pump mayinclude a peristaltic pump configured to receive at least a portion ofthe first section of tubing.

In an aspect, a surgical fluid management system may include a pumpconfigured to deliver fluid to a surgical site; a heater configured toheat the fluid prior to delivery to the surgical site; and a controlsystem operatively connected to the pump and the heater, the controlsystem being configurable to control the pump to deliver the fluid tothe surgical site at at least one of a desired flow rate and a desiredpressure, and to control the heater to warm the fluid to a desiredtemperature.

In a detailed embodiment, the control system may be configured tocontrol the pump by adjusting a speed of the pump to maintain thedesired flow rate. In a detailed embodiment, the control system isconfigured to control the heater by adjusting the heater to maintain thedesired fluid temperature based on an inlet fluid temperature, an outletfluid temperature, and the flow rate.

In an aspect, a disposable tubing and cartridge set for a surgical fluidmanagement may include a connector adapted to couple with a fluid supplycontainer; a heating cartridge configured to be received within a heaterassembly of a surgical fluid management system; a trumpet valve; anupstream irrigation tubing section fluidicly coupling the connector andthe heating cartridge; a downstream irrigation tubing section fluidiclycoupling the heating cartridge and the trumpet valve; and a suctiontubing section fluidicly coupled to the trumpet valve and including anend configured for coupling to a fluid collection container.

In a detailed embodiment, the trumpet valve may include a tip configuredfor suction and irrigation. In a detailed embodiment, the probe mayinclude an electrosurgical tip.

In an aspect, a surgical fluid management system may include a pumpconfigured to deliver fluid to a body cavity for distention of the bodycavity; a remote pressure sensor configured for placement in the bodycavity; and a control system operatively connected to the pump and theremote pressure sensor, the control system being configured to receive,from the remote pressure sensor, a signal associated with a pressure ofthe fluid within the body. The control system may be configured toadjust a speed of the pump to maintain a desired fluid pressure based atleast in part upon the signal from the remote pressure sensor.

In a detailed embodiment, the control system may be configured toreceive at least one of a pneumatic signal or an electrical signal fromthe remote pressure sensor.

In an aspect, a method for operating surgical fluid management systemmay include delivering fluid from a fluid supply container to a surgicalsite via a tubing set; sensing a system fluid pressure in the tubing setbetween the fluid supply container and the surgical site; sensing asurgical site fluid pressure using a remote pressure sensor disposedapproximate the surgical site; and controlling a pressure of the fluiddelivered to the surgical site based at least in part upon at least oneof the sensed system fluid pressure and the sensed surgical site fluidpressure.

In a detailed embodiment, controlling the pressure of the fluiddelivered to the surgical site may be based at least in part upon boththe sensed system fluid pressure and the sensed surgical site fluidpressure. In a detailed embodiment, the tubing set may include adisposable tubing set including a pressure relief valve.

In an aspect, a suction container support assembly may include a suctioncontainer support including a plurality of openings, each of theplurality of openings being configured to receive an individual suctioncontainer therein; and a base comprising at least three spaced-apartload cells, the suction container support being substantially supportedby the at least three spaced-apart load cells. The plurality of openingsmay be arranged such that individual centers of mass of the suctioncontainers received within the openings may be disposed inwardly withrespect to the spaced-apart load cells.

In a detailed embodiment, the base may include four substantiallysymmetrically spaced-apart load cells and/or the suction containersupport may include four substantially symmetrically arranged openings.

In a detailed embodiment, individual ones of the plurality of openingsmay be independently adjustable to receive suction containers of aplurality of sizes. In a detailed embodiment, a suction containersupport assembly may include, for each of the plurality of openings, agenerally radially slidable adjuster, the adjusting being selectivelysecurable in a desired position by a respective knob.

In an aspect, a method of operating a surgical fluid management systemmay include delivering fluid to a surgical site using a pump; andcontrolling operation of the pump based at least in part upon a pressuretrend, the pressure trend including a current measured pressure ascompared to a set point pressure and a previous measured pressure ascompared to the set point pressure.

In a detailed embodiment, controlling operation of the pump may includeclassifying the previous measured pressure as compared to the set pointpressure as corresponding to one of a plurality of zones and/orclassifying the current measured pressure as compared to the set pointpressure as corresponding to one of the plurality of zones.

In a detailed embodiment, the plurality of zones may include a firstzone less than a lowest value of a set point tolerance band, a secondzone between the lowest value of the set point tolerance band and theset point, a third zone between the set point and the highest value ofthe set point tolerance band, a fourth zone between the highest value ofthe set point tolerance band and a high pressure alarm level, and/or afifth zone above the high pressure alarm level. In a detailedembodiment, controlling operation of the pump may include selecting oneof a plurality of control modes based at least in part upon the zonecorresponding to the current measured pressure and the zonecorresponding to the previous measured pressure.

In a detailed embodiment, the plurality of control modes may include atleast one of a slope mode, the slope mode including calculating adesired rate of pressure change, and adjusting operation of the pump toachieve the desired rate of pressure change; an integral control mode,the integral control mode including calculating an integral of apressure error over time, the pressure error being determined bysubtracting a respective measured pressure from the set point pressure,and adjusting operation of the pump to incrementally adjust a fluid flowrate based at least in part upon the integral of the pressure error; acoast mode, the coast mode including substantially maintaining a speedof the pump; a reduction mode, the reduction mode including, if thecurrent measured pressure is less than the previous measure pressure,substantially maintaining the speed of the pump, and, if the currentmeasured pressure is not less than the previous measured pressure,reducing the speed of the pump; and/or a reverse mode, the reverse modeincluding reversing operation of the pump until a subsequent measuredpressure is below a desired pressure level.

In a detailed embodiment, in the integral control mode, adjustingoperation of the pump to incrementally adjust the fluid flow rate mayinclude adjusting operation of the pump to change the fluid flow rate inincrements of about ±1 ml/min. In a detailed embodiment, in thereduction mode, if the current measured pressure is not less than theprevious measured pressure, reducing the speed of the pump based atleast in part upon a difference between the current measured pressureand the set point pressure.

In a detailed embodiment, selecting one of the plurality of controlmodes based at least in part upon the zone corresponding to the currentmeasured pressure and the zone corresponding to the previous measuredpressure may include, if the current measured pressure corresponds tothe second zone and the previous measured pressure corresponds to thefirst zone, selecting the slope control mode; if the current measuredpressure corresponds to the third zone and the previous measuredpressure corresponds to the second zone, selecting the integral controlmode; if the current measured pressure corresponds to the fourth zoneand the previous measured pressure corresponds to the third zone and ifthe fluid flow rate is greater than 0, selecting the reduction mode; ifthe current measured pressure corresponds to the fourth zone and theprevious measured pressure corresponds to the third zone and if thefluid flow rate is not greater than 0, selecting the reverse mode; ifthe current measured pressure corresponds to the fifth zone and theprevious measured pressure corresponds to the fourth zone and if thefluid flow rate is not greater than 0, selecting the reduction mode; ifthe current measured pressure corresponds to the fifth zone and theprevious measured pressure corresponds to the fourth zone and if thefluid flow rate is not greater than 0, selecting the reverse mode; ifthe current measured pressure corresponds to the fourth zone and theprevious measured pressure corresponds to the fifth zone and if thefluid flow rate is not greater than 0, selecting the reduction mode; ifthe current measured pressure corresponds to the fourth zone and theprevious measured pressure corresponds to the fifth zone and if thefluid flow rate is not greater than 0, selecting the reverse mode; ifthe current measured pressure corresponds to the third zone and theprevious measured pressure corresponds to the fourth zone or the fifthzone, selecting the coast mode; if the current measured pressurecorresponds to the second zone and the previous measured pressurecorresponds to the third zone, selecting the integral control mode;and/or if the current measured pressure corresponds to the second zoneand the previous measured pressure corresponds to the fourth zone or thefifth zone, selecting the slope mode.

In an aspect, a method of operating a surgical fluid management systemmay include delivering fluid to a surgical site using a pump; andcontrolling operation of the pump including selecting one of a pluralityof pressure control modes based at least in part upon measuredconditions, and adjusting operation of the pump using the selectedcontrol mode.

In a detailed embodiment, the plurality of pressure control modes mayinclude at least one of a slope mode, the slope mode includingcalculating a desired rate of pressure change, and adjusting operationof the pump to achieve the desired rate of pressure change; an integralcontrol mode, the integral control mode including calculating anintegral of a pressure error over time, the pressure error beingdetermined by subtracting a respective measured pressure from the setpoint pressure, and adjusting operation of the pump to incrementallyadjust a fluid flow rate based at least in part upon the integral of thepressure error; a coast mode, the coast mode including substantiallymaintaining a speed of the pump; a reduction mode, the reduction modeincluding, if the current measured pressure is less than the previousmeasure pressure, substantially maintaining the speed of the pump, and,if the current measured pressure is not less than the previous measuredpressure, reducing the speed of the pump; and/or a reverse mode, thereverse mode including reversing operation of the pump until asubsequent measured pressure is below a desired pressure level.

In a detailed embodiment, in the integral control mode, adjustingoperation of the pump to incrementally adjust the fluid flow rate mayinclude adjusting operation of the pump to change the fluid flow rate inincrements of about ±1 ml/min. In a detailed embodiment, in thereduction mode, if the current measured pressure is not less than theprevious measured pressure, reducing the speed of the pump based atleast in part upon a difference between the current measured pressureand the set point pressure.

In a detailed embodiment, selecting the one of the plurality of pressurecontrol modes based at least in part upon measured conditions mayinclude classifying a previous measured pressure as compared to a setpoint pressure as corresponding to one of a plurality of zones;classifying a current measured pressure as compared to the set pointpressure as corresponding to one of the plurality of zones; and/orselecting the one of the plurality of pressure control modes based atleast in part upon the zone corresponding to the current measuredpressure and the zone corresponding to the previous measured pressure.

In a detailed embodiment, the plurality of zones may include a firstzone less than a lowest value of a set point tolerance band, a secondzone between the lowest value of the set point tolerance band and theset point, a third zone between the set point and the highest value ofthe set point tolerance band, a fourth zone between the highest value ofthe set point tolerance band and a high pressure alarm level, and afifth zone above the high pressure alarm level.

In a detailed embodiment, selecting the one of the plurality of pressurecontrol modes may include, if the current measured pressure correspondsto the second zone and the previous measured pressure corresponds to thefirst zone, selecting the slope control mode; if the current measuredpressure corresponds to the third zone and the previous measuredpressure corresponds to the second zone, selecting the integral controlmode; if the current measured pressure corresponds to the fourth zoneand the previous measured pressure corresponds to the third zone and ifthe fluid flow rate is greater than 0, selecting the reduction mode; ifthe current measured pressure corresponds to the fourth zone and theprevious measured pressure corresponds to the third zone and if thefluid flow rate is not greater than 0, selecting the reverse mode; ifthe current measured pressure corresponds to the fifth zone and theprevious measured pressure corresponds to the fourth zone and if thefluid flow rate is not greater than 0, selecting the reduction mode; ifthe current measured pressure corresponds to the fifth zone and theprevious measured pressure corresponds to the fourth zone and if thefluid flow rate is not greater than 0, selecting the reverse mode; ifthe current measured pressure corresponds to the fourth zone and theprevious measured pressure corresponds to the fifth zone and if thefluid flow rate is not greater than 0, selecting the reduction mode; ifthe current measured pressure corresponds to the fourth zone and theprevious measured pressure corresponds to the fifth zone and if thefluid flow rate is not greater than 0, selecting the reverse mode; ifthe current measured pressure corresponds to the third zone and theprevious measured pressure corresponds to the fourth zone or the fifthzone, selecting the coast mode; if the current measured pressurecorresponds to the second zone and the previous measured pressurecorresponds to the third zone, selecting the integral control mode;and/or if the current measured pressure corresponds to the second zoneand the previous measured pressure corresponds to the fourth zone or thefifth zone, selecting the slope mode.

In an aspect, a tubing and cartridge set for a surgical fluid managementsystem configured to receive fluid from a fluid supply container and todeliver the fluid to a surgical instrument may include a heatingcartridge configured to be releasably received in a heater assembly, theheating cartridge including a three-dimensional fluid path therethrough;an upstream tubing section fluidicly interposing a fluid supplycontainer and the heating cartridge; and a downstream tubing sectionfluidicly interposing the heating cartridge and a surgical instrument.

In a detailed embodiment, the three-dimensional fluid path may include afirst fluid channel oriented in a first direction, a second fluidchannel oriented in a second direction, the second direction beingsubstantially opposite the first direction, and a port fluidiclyconnecting the first fluid channel to the second fluid channel. Thefirst fluid channel may be disposed on a first side of a main body ofthe heating cartridge, the second fluid channel may be disposed on asecond side of the main body of the heating cartridge, the first fluidchannel may face outwardly from the first side of the heating cartridge,and/or the second fluid channel may face outwardly from the second sideof the heating cartridge.

In a detailed embodiment, the three-dimensional fluid path may include athird fluid channel on the second side of the main body and generallyadjacent to the second fluid channel, the third fluid channel beingoriented generally in the first direction. The three-dimensional fluidpath may include a fourth fluid channel on the first side of the mainbody and generally adjacent to the first fluid channel, the fourth fluidchannel being oriented generally in the second direction. The thirdfluid channel may face outwardly from the second side of the heatingcartridge and/or the fourth fluid channel may face outwardly from thefirst side of the heating cartridge.

In a detailed embodiment, the heating cartridge may include a first sidesheet affixed to the first side of the main body and a second side sheetaffixed to the second side of the main body. The first side sheet may atleast partially define outwardly facing aspects of the first fluidchannel and the fourth fluid channel and/or the first fluid channel andthe fourth fluid channel may be disposed substantially against the firstside sheet. The second side sheet may at least partially defineoutwardly facing aspects of the second fluid channel and the third fluidchannel and/or the second fluid channel and the third fluid channel maybe disposed substantially against the second side sheet.

In a detailed embodiment, a tubing and cartridge set may include afitting configured to releasably couple with a corresponding fittingassociated with the heater assembly upon insertion of the heatingcartridge into the heater assembly and/or the fitting may be fluidiclyconnected to the fluid path. In a detailed embodiment, a tubing andcartridge set may include a hydrophobic filter fluidicly interposing thefitting and the fluid path, the hydrophobic filter being operative toprevent fluid from flowing from the fluid path through the fitting.

In a detailed embodiment, the heating cartridge may include at least onebubble trap configured to vent gas from the fluid path. In a detailedembodiment, the bubble trap may include an umbrella valve arranged toallow the gas to escape the fluid path without allowing air to enter thefluid path.

In an aspect, a cartridge for a surgical fluid management system mayinclude an internal fluid path including a first channel extending alonga first side of the cartridge,

a first through-port to a second side of the cartridge, a second channelextending along the second side of the cartridge, a turn section, athird channel extending along the second side of the cartridge, a secondthrough-port to the first side of the cartridge, and a fourth channelextending along the first side of the cartridge.

In a detailed embodiment, the first channel, the second channel, thethird channel, and the fourth channel have generally flattened shapes.In a detailed embodiment, the first channel, the second channel, thethird channel, and the fourth channel have lengths and heights which aresubstantially greater than their thicknesses.

In a detailed embodiment, a cartridge may include an inlet fittingfluidicly connected to the first channel, and an outlet fittingfluidicly connected to the fourth channel. In a detailed embodiment, acartridge may include a first bubble trap between the inlet fitting andthe first channel. In a detailed embodiment, a cartridge may include asecond bubble trap between the fourth channel and the outlet fitting. Ina detailed embodiment, at least one of the first bubble trap and thesecond bubble trap may include a hydrophobic membrane. The hydrophobicmembrane may be disposed within the cartridge such that the hydrophobicmembrane is canted with respect to vertical when the cartridge is inuse, the hydrophobic membrane being canted towards a fluid-contactingside.

In a detailed embodiment, a cartridge may include a substantially rigidmain body and two relatively flexible side sheets, the main body and theside sheets defining the first channel, the second channel, the thirdchannel, and the fourth channel. In a detailed embodiment, the main bodymay include molded polycarbonate; the side sheets may be constructedfrom polycarbonate and welded to the main body.

In a detailed embodiment, a cartridge may include a pressure sensorfitting configured to couple with a corresponding fitting in a heaterassembly upon insertion of the cartridge into the heater assembly. Thepressure sensor fitting may be fluidicly connected to the internal fluidpath. In a detailed embodiment, a cartridge may include a hydrophobicfilter fluidicly interposing the pressure sensor fitting and theinternal fluid path, the hydrophobic filter being operative to preventfluid from flowing through the pressure sensor fitting. In a detailedembodiment, a cartridge may include a pressure sensor fluid pathfluidicly connecting the internal fluid path and the hydrophobic filter.The pressure sensor fluid path may be configured to retain a volume ofgas adjacent to the hydrophobic filter.

In an aspect, a heater assembly for a surgical fluid management devicemay include a slot configured to receive a cartridge slidably therein; afirst infrared lamp mounted adjacent a first side of the slot; a secondinfrared lamp mounted adjacent the first side of the slot; a thirdinfrared lamp mounted adjacent a second side of the slot; and a fourthinfrared lamp mounted adjacent the second side of the slot. The firstinfrared lamp may be substantially elongated and/or may be configured toheat fluid within a first flow channel of the cartridge, the secondinfrared lamp may be substantially elongated and/or may be configured toheat fluid within a second flow channel of the cartridge, the thirdinfrared lamp may be substantially elongated and/or may be configured toheat fluid within a third flow channel of the cartridge, and/or thefourth infrared lamp may be substantially elongated and/or may beconfigured to heat fluid within a fourth flow channel of the cartridge.At least one of the first infrared lamp, the second infrared lamp, thethird infrared lamp, and/or the fourth infrared lamp may be mountedgenerally parallel with a respective one of the first flow channel, thesecond flow channel, the third flow channel, and/or the fourth flowchannel.

In a detailed embodiment, the first infrared lamp and the secondinfrared lamp may be operatively connected to be controlled as a pair;the third infrared lamp and the fourth infrared lamp may be operativelyconnected to be controlled as a pair; and fluid may flow through thecartridge from the first flow channel to the second flow channel, fromthe second flow channel to the third flow channel, and from the thirdflow channel to the fourth flow channel.

In a detailed embodiment, a heater assembly may include an inlettemperature sensor, an intermediate temperature sensor, and/or a outlettemperature sensor. The first flow channel and the second flow channelmay be fluidicly between the inlet temperature sensor and theintermediate temperature sensor, and the third flow channel and thefourth flow channel may be fluidicly between the intermediatetemperature sensor and the outlet temperature sensor. A level of powerapplied to the first infrared lamp and the second infrared lamp may bedetermined at least in part by a signal from the inlet temperaturesensor and/or a level of power applied to the third infrared lamp andthe fourth infrared lamp may be determined at least in part by a signalfrom the outlet temperature sensor.

In a detailed embodiment, a heater assembly may include a firstreflector associated with the first infrared lamp and arranged to directinfrared energy emitted by the first infrared lamp onto the first flowchannel, a second reflector associated with the second infrared lamp andarranged to direct infrared energy emitted by the second infrared lamponto the second flow channel, a third reflector associated with thethird infrared lamp and arranged to direct infrared energy emitted bythe third infrared lamp onto the third flow channel, and/or a fourthreflector associated with the fourth infrared lamp and arranged todirect infrared energy emitted by the fourth infrared lamp onto thefourth flow channel. In a detailed embodiment, at least a portion of atleast one of the first reflector, the second reflector, the thirdreflector, and/or the fourth reflector may be shaped, in cross-section,generally as at least a portion of an ellipse. In a detailed embodiment,one of the first infrared lamp, second infrared lamp, third infraredlamp, and/or fourth infrared lamp may be located proximate a first fociof the ellipse and/or at least a portion of at least one of the firstflow channel, the second flow channel, the third flow channel, and/orthe fourth flow channel may be located proximate a second foci of theellipse.

In an aspect, a surgical fluid management system may include a heaterassembly including elongated infrared lamps located adjacent to a slot;a heating cartridge incorporating a three-dimensional fluid pathincluding a plurality of fluid channels, the heating cartridge beingreceivable within the slot such that the elongated infrared lamps aredisposed generally adjacent to the fluid channels; and a control systemoperatively connected to the elongated infrared lamps, the controlsystem being configured to adjust power to the elongated infrared lampsbased on fluid temperature and flow rate to heat the fluid to a desiredtemperature.

In a detailed embodiment, the control system may be operative to adjustpower to the elongated infrared lamps using pulse width modulation. In adetailed embodiment, the heater assembly may include an individualelongated infrared lamp located generally adjacent to each of the fluidchannels. In a detailed embodiment, each individual elongated infraredlamp may be mounted generally parallel to its respective fluid channel.In a detailed embodiment, the control system may be configured to supplydifferent levels of power to different lamps, thereby applying differentlevels of power to different fluid channels in response to fluidtemperature and flow rate conditions.

In a detailed embodiment, a surgical fluid management system may includeat least one reflector arranged to direct infrared energy emitted by atleast one of the elongated infrared lamps towards at least one of thefluid channels. In a detailed embodiment, the at least one reflector maybe arranged to minimize exposure of portions of the heating cartridgeother than the fluid channels. In a detailed embodiment, the at leastone reflector may be integrated with the elongated lamp. In a detailedembodiment, the at least one reflector may include a reflector shroudmounted generally adjacent to the elongated infrared lamp.

In an aspect, a surgical fluid management system may include a heaterassembly including a slot including a first side and a second side, afirst elongated infrared lamp mounted generally adjacent to the firstside of the slot, a second elongated infrared lamp mounted generallyadjacent to the second side of the slot, a third elongated infrared lampmounted generally adjacent to the second side of the slot, a fourthelongated infrared lamp mounted generally adjacent to the first side ofthe slot; a heating cartridge receivable within the slot and including afirst fluid channel and a second fluid channel arranged such that whenthe heating cartridge is received within the slot, the first fluidchannel may be disposed between the first elongated infrared lamp andthe second elongated infrared lamp and/or the second fluid channel maybe disposed between the third elongated infrared lamp and the fourthelongated infrared lamp; and a control system configured toindependently control at least a first group including the firstelongated infrared lamp and the second elongated infrared lamp and asecond group including the third infrared lamp and the fourth infraredlamp, so as to selectively apply different levels of power to the firstfluid channel and the second fluid channel.

In a detailed embodiment, the control system may be operative toselectively apply different levels of power to the first fluid channeland the second fluid channel based at least in part upon fluidtemperature and/or flow rate.

In an aspect, a heating cartridge for a surgical fluid management systemmay include a three-dimensional fluid path including a plurality offluid channels, each of the plurality of fluid channels being exposed toan exterior of the heating cartridge to receive infrared energy therein.A first one of the fluid channels may be disposed adjacent to a secondone of the fluid channels to permit heat transfer from the first fluidchannel to the second channel through an interposing wall.

In an aspect, a heating cartridge for a surgical fluid management systemmay include a substantially rigid main body at least partially definingat least one fluid channel; and a substantially flexible side sheetaffixed to the main body, the side sheet at least partially defining theat least one fluid channel, such that the main body and side sheettogether define the at least one fluid channel.

In a detailed embodiment, the side sheet may be sufficiently flexible tosubstantially dampen pulsatile fluid flow through the fluid channel. Ina detailed embodiment, the side sheet may be sufficiently flexible tosubstantially dampen pulsatile fluid flow produced by at least one of aperistaltic pump or a piston pump.

In an aspect, a surgical fluid management system may include a heaterassembly including a slot and a heater assembly pressure sensor fitting;a heater cartridge receivable within the slot, the heater cartridgeincluding a heater cartridge pressure sensor fitting configured tocouple with the heater assembly pressure sensor fitting upon insertionof the heater cartridge into the heater assembly, the heater cartridgepressure sensor fitting being fluidicly connected to at least one fluidchannel within the heater cartridge; and at least one fluid pressuresensor fluidicly connected to the heater assembly pressure sensorfitting, the pressure sensor being operative to measure a pressure of acolumn of air trapped between fluid in the at least one fluid channeland the pressure sensor.

In an aspect, a method of operating a surgical fluid management systemmay include delivering fluid to a surgical site via a heater assembly,the heater assembly including at least a first heater and a secondheater, the fluid flowing past the first heater and then flowing pastthe second heater; supplying power to the first heater based at least inpart upon an estimated power requirement, the estimated powerrequirement being substantially proportional to a flow rate of the fluidand a total desired temperature change of the fluid; and supplying powerto the second heater, including, if a current outlet temperature is lessthan a set point outlet temperature by greater than a predeterminedthreshold, supplying power to the second heater based upon a firstheater control algorithm, and, if the current outlet temperature is lessthan the set point outlet temperature by less than a predeterminedthreshold, supplying power to the second heater based upon a secondheater control algorithm.

In a detailed embodiment, supplying power to the first heater mayinclude supplying power to the first heater based at least in part upona load factor multiplied by the estimated power requirement. In adetailed embodiment, supplying power to the second heater may includecutting off power to the second heater if a predetermined threshold rateof pressure increase is reached.

In a detailed embodiment, the first heater control algorithm may includea proportional control algorithm, the proportional control algorithmincluding multiplying the estimated power requirement by a proportionalcontrol factor, the proportional control factor varying with thetemperature error, the temperature error being a difference between aset point outlet temperature and a current outlet temperature. In adetailed embodiment, the proportional control factor may be given by

${k_{1} + \frac{{temperature\_ error}^{2}}{k_{2}}},$

where k₁ and k₂ are constants.

In a detailed embodiment, the second heater control algorithm mayinclude an integral control algorithm, the integral control algorithmincluding calculating an integral of the temperature error over time,the temperature error being a difference between a set point outlettemperature and a current outlet temperature; if the integral of thetemperature error over time is less than a predetermined negative value,incrementally reducing the power supplied to the second heater; if theintegral of the temperature error over time is greater than apredetermined positive value, incrementally increasing the powersupplied to the second heater; and if the integral of the temperatureerror over time is between the predetermined negative value and thepredetermined positive value, maintaining the power supplied to thesecond heater.

In a detailed embodiment, incrementally reducing the power supplied tothe second heater and incrementally increasing the power supplied to thesecond heater may include adjusting the power supplied to the secondheater in increments of about 1% of a maximum power of the secondheater. In a detailed embodiment, supplying power to the second heaterbased upon the integral control algorithm may include applying areduction factor to the power supplied to the second heater, thereduction factor decreasing from about 1.0 to about 0 as the currentoutlet temperature increases to reach and exceed the set point outlettemperature.

In an aspect, a method of monitoring a fluid deficit in a surgical fluidmanagement system may include measuring an initial weight held by afluid supply container support, the fluid supply container supportsupporting a first fluid supply container; measuring an initial weightheld by a fluid collection container support, the fluid collectioncontainer support supporting a first fluid collection container;calculating an initial reference total weight, the initial referencetotal weight including a sum of the initial fluid supply containersupport weight and the initial fluid collection container supportweight; supplying fluid from the first fluid supply container to asurgical site; collecting at least some of the fluid from the surgicalsite into the first fluid collection container; measuring a firstcurrent weight held by the fluid supply container support; measuring afirst current weight held by the fluid collection container support;calculating a first current total weight, the first current total weightincluding a sum of the first current weight held by the fluid supplycontainer support and the first current weight held by the fluidcollection container support; and calculating a first fluid deficit bysubtracting the first current total weight from the initial referencetotal weight.

In a detailed embodiment, a method may include, prior to measuring theinitial weight held by the fluid supply container support and prior tomeasuring the initial weight held by the fluid collection containersupport, priming a tubing set.

In a detailed embodiment, a method may include, after calculating thefirst fluid deficit, supplying fluid from the first fluid supplycontainer to the surgical site and collecting at least some of the fluidfrom the surgical site into the first collection container; measuring asecond current weight held by the fluid supply container support;measuring a second current weight held by the fluid collection containersupport; calculating a second current total weight, the second currenttotal weight including a sum of the second current weight held by thefluid supply container support and the second current weight held by thefluid collection container support; and calculating a second fluiddeficit by subtracting the second current total weight from the initialreference total weight.

In a detailed embodiment, a method may include, after calculating thesecond fluid deficit, accounting for replacement of the first fluidsupply container with a second fluid supply container by prior toreplacement of the first fluid supply container with the second fluidsupply container, measuring a pre-replacement weight held by the fluidsupply container support; after replacement of the first fluid supplycontainer by the second fluid supply container, measuring apost-replacement weight held by the fluid supply container support;calculating a fluid supply container weight difference by subtractingthe pre-replacement weight from the post-replacement weight; andcalculating an updated reference total weight, the updated referencetotal weight including the sum of the initial reference total weight andthe fluid supply container weight difference.

In a detailed embodiment, a method may include, after calculating theupdated total reference weight, supplying fluid from the second fluidsupply container to the surgical site and collecting at least some ofthe fluid from the surgical site into the first collection container;measuring a third current weight held by the fluid supply containersupport; measuring a third current weight held by the fluid collectioncontainer support; calculating a third current total weight, the thirdcurrent total weight including a sum of the third current weight held bythe fluid supply container support and the third current weight held bythe fluid collection container support; and calculating a third fluiddeficit by subtracting the third current total weight from the updatedreference total weight.

In a detailed embodiment, a method may include detecting replacement ofthe first fluid supply container by the second fluid supply container byascertaining a substantial weight difference between the pre-replacementweight and the post-replacement weight. In a detailed embodiment, thesubstantial weight difference may correspond approximately to apredetermined expected fluid supply container replacement weightdifference. In a detailed embodiment, ascertaining the substantialdifference may include waiting for a period of time to allow dissipationof transient weight signals present due to inadvertent motion of thesurgical fluid management system. In a detailed embodiment, detectingreplacement of the first fluid supply container by the second fluidsupply container may include detecting replacement of a partiallydepleted first fluid supply container by a substantially full secondfluid supply container.

In a detailed embodiment, a method a method may include, aftercalculating the second fluid deficit, accounting for replacement of thefirst fluid collection container with a second fluid collectioncontainer by prior to replacement of the first fluid collectioncontainer with the second fluid collection container, measuring apre-replacement weight held by the fluid collection container support;after replacement of the first fluid collection container by the secondfluid collection container, measuring a post-replacement weight held bythe fluid collection container support; calculating a fluid collectioncontainer weight difference by subtracting the pre-replacement weightfrom the post-replacement weight; and calculating an updated referencetotal weight, the updated reference total weight including the sum ofthe initial reference total weight and the fluid collection containerweight difference.

In a detailed embodiment, a method may include, after calculating theupdated total reference weight, supplying fluid from the first fluidsupply container to the surgical site and collecting at least some ofthe fluid from the surgical site into the second collection container;measuring a third current weight held by the fluid supply containersupport; measuring a third current weight held by the fluid collectioncontainer support; calculating a third current total weight, the thirdcurrent total weight including a sum of the third current weight held bythe fluid supply container support and the third current weight held bythe fluid collection container support; and calculating a third fluiddeficit by subtracting the third current total weight from the updatedreference total weight.

In a detailed embodiment, a method may include detecting replacement ofthe first fluid collection container by the second fluid collectioncontainer by ascertaining a substantial weight difference between thepre-replacement weight and the post-replacement weight. In a detailedembodiment, the substantial weight difference may correspondapproximately to a predetermined expected fluid collection containerreplacement weight difference.

In an aspect, a method of monitoring a fluid deficit in a surgical fluidmanagement system may include measuring an initial weight held by afluid supply container support, the fluid supply container supportsupporting at least one fluid supply container; measuring an initialweight held by a fluid collection container support, the fluidcollection container support supporting at least one fluid collectioncontainer; calculating an initial reference total weight, the initialreference total weight including a sum of the initial fluid supplycontainer support weight and the initial fluid collection containersupport weight; supplying fluid from the at least one fluid supplycontainer to a surgical site; collecting at least some of the fluid fromthe surgical site into the at least one fluid collection container;monitoring a current weight held by the fluid supply container support;monitoring a current weight held by the fluid collection containersupport; calculating a current total weight, the current total weightincluding a sum of the current weight held by the fluid supply containersupport and the current weight held by the fluid collection containersupport; and calculating a current fluid deficit by subtracting thecurrent total weight from the initial reference total weight.

In a detailed embodiment, a method may include accounting forreplacement of the at least one fluid supply container with a new fluidsupply container including sensing a significant difference between apre-replacement fluid supply container support weight and apost-replacement fluid supply container support weight; calculating afluid supply container weight difference by subtracting thepre-replacement fluid supply container support weight from thepost-replacement fluid supply container support weight; calculating anupdated reference total weight, the updated reference total weightincluding the sum of the initial reference total weight and the fluidsupply container weight difference; and using the updated referencetotal weight in subsequent deficit calculations.

In a detailed embodiment, a method may include accounting forreplacement of the at least one fluid collection container with a newfluid collection container including sensing a significant differencebetween a pre-replacement fluid collection container support weight anda post-replacement fluid collection container support weight;calculating a fluid collection container weight difference bysubtracting the pre-replacement fluid collection container supportweight from the post-replacement fluid collection container supportweight; calculating an updated reference total weight, the updatedreference total weight including the sum of the initial reference totalweight and the fluid collection container weight difference; and usingthe updated reference total weight in subsequent deficit calculations.

In a detailed embodiment, a method may include repeating the monitoringthe current weight held by the fluid supply container support,monitoring the current weight held by the fluid collection containersupport, calculating the current total weight, and calculating thecurrent fluid deficit operations to provide a substantially continuouslyupdated fluid deficit calculation.

In an aspect, a method of operating a surgical fluid management devicemay include calculating an initial reference total weight, the initialreference total weight including a sum of an initial weight of a fluidsupply container and an initial weight of a fluid collection container;supplying fluid from the fluid supply container to a surgical site;collecting at least some of the fluid from the surgical site into thefluid collection container; calculating a current total weight, thecurrent total weight including a sum of a current weight of the fluidsupply container and a current weight of the fluid collection container;and calculating a deficit by subtracting the current total weight fromthe initial reference total weight.

In a detailed embodiment, a method may include detecting replacement ofthe fluid supply container by a replacement fluid supply container byascertaining a substantial weight difference between a pre-replacementweight of the fluid supply container and a post-replacement weight ofthe replacement fluid supply container; calculating an updated referencetotal weight, the updated reference total weight including the sum ofthe initial reference total weight and a difference between thepost-replacement weight of the replacement fluid supply container andthe pre-replacement weight of the fluid supply container.

In a detailed embodiment, a method may include supplying fluid from thereplacement fluid supply container to the surgical site; collecting atleast some of the fluid from the surgical site into the fluid collectioncontainer; calculating an updated current total weight, the updatedcurrent total weight including a sum of an updated current weight of thereplacement fluid supply container and an updated current weight of thefluid collection container; and calculating an updated deficit bysubtracting the updated current total weight from the updated referencetotal weight.

In a detailed embodiment, a method may include detecting replacement ofthe fluid collection container by a replacement fluid collectioncontainer by ascertaining a substantial weight difference between apre-replacement weight of the fluid collection container and apost-replacement weight of the replacement fluid collection container;and calculating an updated reference total weight, the updated referencetotal weight including the sum of the initial reference total weight anda difference between the post-replacement weight of the replacementfluid collection container and the pre-replacement weight of the fluidcollection container.

In a detailed embodiment, a method may include supplying fluid from thefluid supply container to the surgical site; collecting at least some ofthe fluid from the surgical site into the replacement fluid collectioncontainer; calculating an updated current total weight, the updatedcurrent total weight including a sum of an updated current weight of thefluid supply container and an updated current weight of the replacementfluid collection container; and calculating an updated deficit bysubtracting the updated current total weight from the updated referencetotal weight.

In an aspect, a method of operating a multi-functional fluid managementsystem may include receiving, via a user interface, at least one of asurgical discipline selection and a surgical procedure selection; andsetting at least one default operating limit based at least in part uponthe at least one of the surgical discipline selection and the surgicalprocedure selection.

In a detailed embodiment, a method may include allowing user-directedoperation below the default operating limit; requiring additionalaffirmative action via the user interface for operation above thedefault operating limit at less than a maximum limit; and precludingoperation above the maximum limit.

In an aspect, a method of operating a surgical fluid management systemmay include receiving, via a user interface, identification ofinformation to be gathered by a surgical fluid management system duringa surgical procedure; electronically storing the information during thesurgical procedure; and receiving, via the user interface, aninstruction pertaining to at least one of printing, storing, and/orelectronically transmitting the information.

In an aspect, a method of operating a multi-functional surgical fluidmanagement system may include receiving, via a user interface,identification of at least one of a surgical discipline and a surgicalprocedure; setting default operating parameters based upon the at leastone of the surgical discipline and the surgical procedure and receiving,via a user interface, input to adjust the operating parameters.

In a detailed embodiment, a method may include receiving, via the userinterface, input pertaining to desired alarm levels and alarm types; andoverriding an alarm received during the surgical procedure based oninput received via the user interface, if conditions have not exceededpre-established maximum levels.

In a detailed embodiment, the alarm types may include at least one ofvisible and audible.

In an aspect, a method of operating a surgical fluid management systemmay include receiving, via a user interface, preferred operatingsettings associated with at least one of a surgical discipline and asurgical procedure, the preferred operating settings also beingassociated with an identity of at least one of a surgeon and anoperator; and setting operating parameters at the preferred operatingsettings upon receiving an input, via a user interface, associated withat least one of the surgeon and the operator and at least one of thesurgical discipline and the surgical procedure.

In an aspect, a surgical fluid management system may include a touchscreen interface, the touch screen interface being configured to receiveuser input pertaining to operating parameters and to displayinformation.

In an aspect, a method of controlling a surgical fluid management devicemay include receiving, via a user input, identification of informationwhich must be entered prior to operation of a surgical fluid managementdevice; requesting entry of the information; if the information has notbeen entered, precluding operation of the of the surgical fluidmanagement device; and if the information has been entered, allowingoperation of the surgical fluid management device.

In accordance with another aspect of the present invention, there isprovided a fluid management system for supplying fluids of at least twotypes, said system comprising: at least one fluid supply container; atleast one fluid collection container; a pump configured to deliver afluid from the at least one fluid supply container to a site, said sitebeing a surgical site or a patient; a control system for operating thefluid management system in at least one of (1) a pressure control mode,wherein said control system controls the pump to deliver fluid to thesite at approximately a target pressure or (2) a flow control mode,wherein the control system controls the pump to deliver fluid to thesite at approximately a target flow rate. The control system includes auser interface for communication between the control system and a user,including inputting data to the control system and outputting data fromthe control system; a fluid deficit monitoring function for determininga fluid deficit that is a difference between (i) a volume of fluiddelivered to the site from the at least one fluid supply container and(ii) a volume of fluid returned from the site to the at least one fluidcollection container; and a fluid deficit alarm function for activatinga fluid deficit alarm when a fluid deficit exceeds a fluid deficit alarmlimit indicative of a maximum fluid deficit associated with a type offluid communicated to the control system.

In accordance with still another aspect of the present invention, thereis provided a method of operating a fluid management system forsupplying fluids of at least two types, wherein said system includes atleast one fluid supply container, at least one fluid collectioncontainer, a pump configured to deliver a fluid from the at least onefluid supply container to a site, said site being a surgical site or apatient; and a control system for controlling operation of the fluidmanagement system. The method includes the steps of: inputting data tothe control system and outputting data from the control system via auser interface; selecting a medical procedure that requires (1) apressure control mode, wherein said control system controls the pump todeliver fluid to the site at approximately a target pressure or (2) aflow control mode, wherein said control system controls the pump todeliver fluid to the site at approximately a target flow rate;determining a fluid deficit that is a difference between (i) a volume offluid delivered to the site from the at least one fluid supply containerand (ii) a volume of fluid returned from the site to the at least onefluid collection container; associating a fluid deficit alarm limit witha type of fluid being supplied by the at least one fluid supplycontainer; and activating a fluid deficit alarm when the fluid deficitexceeds the fluid deficit alarm limit associated with the type of fluidbeing supplied by the at least one fluid supply container.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description refers to the following figures in which:

FIG. 1 is a perspective view of an exemplary surgical fluid managementsystem;

FIG. 2 is a front elevation view of an exemplary surgical fluidmanagement system with the door open;

FIG. 3 is a front elevation cross-section view of an exemplary surgicalfluid management system;

FIG. 4 is a perspective view of an exemplary fluid bag hanger assembly;

FIG. 5 is a perspective view of an exemplary suction container hangerassembly;

FIG. 6 is a cross-sectional view of an exemplary suction containerhanger assembly;

FIG. 7 is a bottom view of an exemplary suction container hangerassembly;

FIG. 8 is a perspective view of an exemplary load cell base;

FIG. 9 is a schematic illustration of an exemplary trumpet valve tubingset;

FIG. 10 is an exploded perspective view of an exemplary heatingcartridge;

FIG. 11 is a perspective view of an exemplary heating cartridge;

FIG. 12 is a perspective view of an exemplary heating cartridge;

FIG. 13 is a perspective view of a heating cartridge illustrating anexemplary three-dimensional fluid flow path;

FIG. 14 is a perspective view of a heating cartridge illustration anexemplary bubble trap;

FIG. 15 is a perspective view of an exemplary heater assembly;

FIG. 16 is a side view of an exemplary heater assembly;

FIG. 17 is a side view of an exemplary heater assembly;

FIG. 18 is a cross-sectional view of an exemplary heater assembly;

FIG. 19 is a cross-sectional view of an exemplary heater assembly;

FIG. 20 is a schematic illustration of an exemplary power and controlsystem;

FIG. 21 is a schematic illustration of an exemplary equipment setuputilizing multi-stage heating;

FIG. 22 is a schematic diagram of an exemplary equipment setup for usewith a trumpet valve;

FIG. 23 is a schematic diagram of an exemplary equipment setup for usewith an electrosurgical device;

FIG. 24 is a schematic diagram of an exemplary equipment setup for usewith a tubing set including one or more connectors for connecting to asurgical instrument;

FIG. 25 is a schematic diagram of an exemplary equipment setup forinfusion;

FIG. 26 is a perspective view of an alternative exemplary heatingcartridge;

FIG. 27 is an exploded perspective view of an alternative exemplaryheating cartridge;

FIG. 28 is an exploded perspective view of an alternative exemplaryheating cartridge;

FIG. 29 is a screen shot of an exemplary setup screen;

FIG. 30 is a screen shot of an exemplary tubing set selection screen;

FIG. 31 is a screen shot of an exemplary surgical discipline selectionscreen;

FIG. 32 is a screen shot of an exemplary procedure selection screen;

FIG. 33 is a screen shot of an exemplary physician selection screen;

FIG. 34 is a screen shot of an exemplary operator selection screen;

FIG. 35 is a screen shot of an exemplary control mode selection screen

FIG. 36 is a screen shot of an exemplary priming screen;

FIG. 37 is a screen shot of an exemplary secondary display and printercontrol screen;

FIG. 38 is a screen shot of an exemplary run screen;

FIG. 39 is a screen shot of an exemplary summary screen;

FIG. 40 is a screen shot of an exemplary supervisor screen;

FIG. 41 is a flowchart illustrating an example method of operating asurgical fluid management system;

FIG. 42 is a flowchart illustrating an example method of operating asurgical fluid management system;

FIG. 43 is a flowchart illustrating an example method of operating asurgical fluid management system;

FIG. 44 is a flowchart illustrating an example method of operating asurgical fluid management system;

FIG. 45 is a flowchart illustrating an example method of monitoring afluid deficit in a surgical fluid management system;

FIG. 46 is a flowchart illustrating an example method of monitoring afluid deficit in a surgical fluid management system;

FIG. 47 is a flowchart illustrating an example method of operating asurgical fluid management system;

FIG. 48 is a flowchart illustrating an example method of operating amulti-functional fluid management system;

FIG. 49 is a flowchart illustrating an example method of operating asurgical fluid management system;

FIG. 50 is a flowchart illustrating an example method of operating amulti-functional surgical fluid management system;

FIG. 51 is a flowchart illustrating an example method of operating asurgical fluid management system;

FIG. 52 is a flowchart illustrating an example method for of controllinga surgical fluid management device;

FIG. 53A illustrates a tubing set having detachable proximal and distalportions, according to a first embodiment;

FIG. 53B illustrates a tubing set having detachable proximal and distalportions, according to a second embodiment; and

FIG. 54 is a block diagram illustrating an embodiment of the controlsystem for the fluid management system that includes an RFID interface.

DETAIL DESCRIPTION OF THE INVENTION

The present disclosure includes, inter alia, surgical fluid managementsystems and methods for using surgical fluid management systems.

The present disclosure contemplates that various fluids (such asirrigation fluids) may be employed during surgical procedures for manypurposes, such as (and without limitation) to wash away blood and/ordebris from a surgical site to provide the surgeon with an improved viewand/or to distend a surgical site (such as during some gynecological,urological, and orthopedic procedures, for example). In addition, thepresent disclosure contemplates that fluids may be infused into apatient. For example, various fluids (including fluids comprisingpharmaceuticals and/or blood components) may be intravenously infusedinto a patient.

Further, the present disclosure contemplates that a patient's core bodytemperature may be reduced if a low-temperature irrigation and/orinfusion fluid is employed. Thus, the use of low-temperature fluids(which may refer to fluids at temperatures less than a patient's bodytemperature) may contribute to hypothermia, which may be a reduction ina patient's body temperature of about 2° C. or more. For example, theuse of low-temperature irrigation fluid during a surgical procedure maycontribute to intraoperative hypothermia. Similarly, the presentdisclosure contemplates that infusion of low temperature fluids maycontribute to patient hypothermia. The present disclosure contemplatesthat hypothermia may result in adverse patient outcomes and/or increasedmedical costs. Similarly, the present disclosure contemplates that someprocedures may include intentionally lowering a patient's bodytemperature, and, in such circumstances, further lowering of thepatient's body temperature below the desired temperature may result inadverse patient outcomes and/or increased medical costs.

An exemplary fluid management system according to the present disclosuremay provide one or more functions, including irrigation, distention,deficit monitoring, and/or infusion functions, and/or may warm thefluid. An exemplary embodiment may allow a user to select between fluidpressure or flow rate control, to enable or disable fluid warming, tocontrol various operating parameters (such as desired fluid pressure orfluid flow rate, fluid temperature (if the fluid warming feature isenabled), and the like), may display information (such as desired and/oractual fluid pressure, fluid flow rate, and fluid temperature, as wellas fluid volume, volumetric deficit, and the like), and/or may provideone or more alarms (such as an over pressure alarm, over temperaturealarm, low fluid supply alarm, fluid deficit alarm, perforation alarm,and the like). Some exemplary devices may provide data logging and/orprinting capabilities and/or the ability to electronically transmit datato a central data collection or information system. An exemplaryembodiment may warm a fluid to a temperature selected by a user (such asa temperature approximate a patient's body temperature) and/or maydeliver the fluid to the surgical site at a pressure and/or flow rateselected by a user.

FIG. 1 is a perspective view of an exemplary fluid management system 10including a fluid management unit 100. An exemplary fluid managementunit 100 may include one or more fluid container supports, such as fluidbag hangers 102, 104, each of which may support one or more fluid bags902, 904 (and/or other fluid supply containers). Fluid bag hangers 102,104 may receive a variety of sizes of fluid bags 902, 904, such as 1 Lto 5 L bags. An exemplary embodiment may include fluid bag hangers 102,104 at approximately shoulder height, which may minimize the difficultyof hanging fluid bags 902, 904, particularly when large volume fluidbags 902, 904 are employed.

An exemplary fluid management unit 100 may include one or more userinterface components, such as a touch screen display 106. As will bedescribed in detail below, the user interface provides communicationbetween a control system and a user, including inputting data to thecontrol system and outputting data from the control system. The userinterface may provide information to the user in visual and/or audibleforms. Some exemplary embodiments may employ switches, knobs, dials, andthe like as user interface components in addition to or instead of oneor more touch screen displays 106. User interface components, such astouch screen display 106, may enable the user to select fluid pressureor flow rate control, to enable or disable fluid warming functions, toconfigure operating parameters and alarms, to configure information tobe displayed, and/or to configure information to be stored, printed, ortransmitted after the procedure for record keeping purposes.

An exemplary fluid management system 10 may include a secondary display106A, which may be mounted to a display pole 20A. Display pole 20A maybe configured to be extendable (e.g., telescopically) to allowadjustment of the height of secondary display 106A. Such an embodimentmay be useful during procedures in which the surgeon is sitting and/ormust look over an obstruction to view the fluid management system 10.Similarly, some exemplary embodiments may include one or more remotedisplays which may be located away from the fluid management unit 100for the convenience of a user.

Some exemplary fluid management units 100 may include a door 108 orother closure which may at least partially cover various components. Insome exemplary embodiments including a door 108 or other closure, theposition (e.g., shut and/or open) of the door 108 or other closure maybe utilized as an interlock to prevent and/or allow certain operationsof the device.

An exemplary fluid management system 10 may include a suction containerhanger assembly 200. An exemplary suction container hanger assembly 200may support one or more suction canisters 906, 908, 910, 912 (and/orother fluid collection containers) from a suction canister hanger 202.Other exemplary embodiments may employ suction container supportassemblies other than suspension-type assembles. For example, anassembly supporting a suction container from below may be utilizedinstead of or in addition to a suspension-type assembly. In an exemplaryembodiment, one or more suction canisters 906, 908, 910, 912 may becoupled to a suction or vacuum source, such as any of those commonlyfound in a surgical suite. An exemplary suction container hangerassembly 200 may be adapted to accommodate different sizes of suctioncontainers and may be adjustable to accommodate such containers.

An exemplary surgical fluid management unit 100 may be mounted on arolling stand, which may include a pole 20 and/or a base 22, which mayinclude a plurality of castered wheels 26 mounted to a respectiveplurality of legs 24. The base 22 may also include a storage basket 28other similar storage component. Some exemplary embodiments may bemounted to other mobile devices, such as a cart. Some exemplaryembodiments may be mounted in a fixed location, such as an operatingroom, by being affixed to a wall, mounted to other fixed equipment,mounted on a boom, etc.

An exemplary fluid management unit 100 may be utilized with tubing setsthat fluidicly connect various components. Tubing sets may be disposable(to comply with health standards associated with items contacting bodilyfluids, for example), and may be provided sterile and ready for use.Different tubing sets may be utilized for performing different surgicalfunctions. For example, an exemplary irrigation tubing set forlaparoscopic procedures may include generally parallel suction andirrigation tubing, and/or may include a valve device (such as a trumpetvalve) for controlling flow of irrigation fluid and/or suction. Anexemplary tubing set for distention procedures may include generallyparallel delivery and return tubing, which may couple to a surgicalinstrument, such as via standard Luer-lock fittings. Such tubing setsfor distention procedures may incorporate a pressure relief valve toguard against over-pressurization of the body cavity being distended.

FIG. 2 is a detailed front elevation view of an exemplary fluidmanagement unit 100. In FIG. 2, door 108 is open and slot 310 for fluidheating cartridge 410 is visible. An exemplary cartridge 410, describedin further detail below, may be utilized with one or more heat transferdevices (e.g., heaters) to change the temperature of a fluid prior todelivery to a surgical site and/or prior to infusion into a patient. Inan exemplary embodiment, cartridge 410 may be fully enclosed (except forthe connections described below) and/or may be provided as part of adisposable tubing set. By providing a disposable cartridge 410 (and/orother patient or fluid-contacting components) as part of a disposabletubing set, an exemplary fluid management system 10 may providecomponents requiring sterilization prior to use and/or which may contactbodily fluids as disposable components, and/or other components may bedurable. Thus, only minimal cleaning of the non-disposable components offluid management system 10 may be required between patients.

An exemplary embodiment may include a data recording device, such as aprinter 111. An exemplary data recording device may create a permanentand/or temporary record of important information regarding the use ofthe fluid management system 10 during a surgical procedure, such as theidentity of the surgeon, identity of the operator, identity of thepatient (usually by patient number), procedure performed, and procedureduration, as well as various operating conditions such as total fluidvolume utilized, average fluid temperature, minimum and/or maximum fluidtemperatures, alarm conditions, and the like. Those of ordinary skillwill recognize that alternate and/or additional data recording and/orstorage mechanisms may be utilized, such as electronic storagecomponents.

An exemplary fluid management unit 100 may include a handle 110.

An exemplary fluid management unit 100 may include one or more fluidpressurization or transfer devices, such as a pump 112. An exemplarypump 112 may include an electrically driven peristaltic pump. Someexemplary peristaltic pumps may operate at speeds between about 4 and400 revolutions per minute and/or may deliver fluid up to approximately1.4 L/min, for example. Some exemplary embodiments may include othertypes of positive displacement and/or non-positive displacement pumpsknown in the art. Further, some exemplary embodiments may utilizealternative power sources, such as compressed air, vacuum, etc. to drivea pump. Exemplary electrically driven pumps may receive power from aline source (such as a wall outlet) and/or one or more external and/orinternal electrical storage devices (such as a disposable orrechargeable battery). Some exemplary electrically driven pumps mayinclude stepper motors, DC brush motors, AC or DC brushless motors,and/or other similar devices known in the art.

In an exemplary embodiment, fluid bag hangers 102, 104 may include oneor more hooks 114, 116 from which one or more fluid bags 902, 904 may besuspended. In an exemplary embodiment, door 108 may include one or morehinges 117 and/or a latch component 118, which may have a correspondinglatch component 120 on the fluid management unit 100.

Various fluid paths are visible in FIG. 2. For example, a tubing set mayinclude irrigation tubing, which may include tubing extending from oneor more fluid containers (such as fluid bags 902, 904 shown in FIG. 1),through opening 122, through pump 112, into cartridge 410 (which may beprovided as part of the tubing set), out of the cartridge into path 124,and to a hand piece via opening 126. A tubing set may include suctiontubing, which may include tubing extending from a hand piece intoopening 126, through path 128, out of opening 130, and to one or moresuction sources and/or containers, such as suction canisters 906, 908,910, 912.

Some exemplary embodiments may include one or more bubble detectors,such as ultrasonic bubble detector 132, which may be provided along afluid path. Exemplary embodiments may include other types of bubbledetectors and/or liquid detectors (such as optical bubble detectors,infrared bubble detectors, and the like) in place of or in addition toultrasonic bubble detector 132. One or more bubble detectors 132 may beutilized for various purposes as discussed below, such as to detectliquid during priming and/or to detect a bubble in tubing leading to asurgical and/or infusion site. In some exemplary embodiments, one ormore bubble detectors 132 may be used to detect fluid within the tubing,thus indicating that cartridge 410 may be substantially filled withfluid and, therefore, heater assembly 309 may be safely activated, Insome exemplary embodiments, two or more bubble detectors 132 may beutilized to detect bubbles (e.g., in distention and/or infusionapplications), which may provide redundant bubble detection capability.For example, in some distention and/or infusion applications, if anybubble detector 132 detects a bubble, pump 112 may be stopped to reducethe risk of introducing air into the body cavity being distended (whichcould obstruct viewing) or infusing air into a patient.

Some exemplary embodiments may include one or more temperature sensors,such as thermal cut off sensor(s) 2048, which may include one or morebimetal switches, infrared temperature sensors, and/or other temperaturesensors known in the art. Bubble detector(s) 132 and thermal cut offsensor(s) 2048 may be mounted such that they may be in contact withtubing extending through path 124, for example.

In some exemplary embodiments, door 108 may be arranged such that it maynot be fully shut unless the tubing of the tubing set is properlyinserted into the appropriate flow paths. For example, door 108 may bearranged such that it will not fully shut unless cartridge 410 is fullyinserted into slot 310 and/or tubing associated with a tubing set isproperly installed in fluid management unit 100. Fingers 108A on theinside of door 108 may be configured to prevent door 108 from fullyshutting if pump 112 is not in its operational configuration (e.g., door108 may be prevented from closing if the pump head is not closed).Similarly, finger 108C may be configured to press tubing into path 124to promote contact between the tubing and bubble detector 132. Likewise,finger 108B may be configured to press tubing into path 124 to promotecontact between the tubing and thermal cut off sensor(s) 2048.

FIG. 3 is a cross-sectional view of an exemplary fluid management unit100. Some exemplary fluid bag hangers 102, 104 may include rods 134, 136which may be pivotably joined at pivots 138, 140, respectively. In anexemplary embodiment, rods 134, 136 may include a journal 139, 141through which the respective pivot 138, 140 extends. Rods 134, 136 maybe supported by one or more load cells 142, 144, which may outputelectrical signals associated with the weight of the fluid containerssuspended from the fluid bag hangers. In an exemplary embodiment, loadcells 142, 144 may include button-type compression cells. Otherexemplary embodiments may utilize load cells of other types, such asbeam-type load cells and/or strain gauges. An exemplary embodiment mayutilize a signal provided by one or more load cells 142, 144 todetermine a volume of one or more bags of fluid 902, 904 attached to theunit 100 (e.g., whether a given bag of fluid 902 is a 1 L bag, or a 5 Lbag), to determine an amount of fluid remaining in one or more bags offluid 902, 904, and/or to sense when a bag of fluid 902, 904 has beenreplaced, for example. In an exemplary embodiment in which a fluid baghanger 102, 104 is utilized to hang a single fluid bag 902, 904, eachload cell 142, 144 may provide a signal associated with the weight of asingle fluid bag 902, 904.

In some exemplary embodiments, providing one or more integral fluid baghangers 102, 104 may reduce the complexity and/or cost of the fluidmanagement system 10 because wiring associated with the load cells 142,144 may be located within the housing of fluid management unit 100, ascompared to embodiments including fluid bag hangers mounted to asupporting structure (such a pole and cross bar assembly) extendingupwardly from the fluid management unit 100. Specifically, integralfluid bag hangers 102, 104 may obviate the need to run wiring associatedwith one or more load cells along or within an upwardly extendingsupporting structure.

In an exemplary embodiment, a heater assembly 309 may include one ormore heat sources, such as infrared (IR) lamps 312, 314, 316, 318, whichmay be mounted near slot 310. In other exemplary embodiments, othersources of IR energy may be utilized, such as halogen lamps, lightemitting diodes (LEDs), quartz lamps, carbon lamps, and the like. In anexemplary embodiment, IR lamps 312, 314, 316, 318 may draw up to about500 W each, for a total of up to approximately 2 kW, which may provideapproximately a 25° C. temperature rise (or greater) at a flow rate ofapproximately 500 mL/min or greater. Reflector shrouds 320, 322, 324,326 may be mounted to direct IR energy emitted by lamps 312, 314, 316,318 towards cartridge 410, which may be received in slot 310.

FIG. 4 is a detailed perspective view of an exemplary fluid bag hangerassembly.

FIGS. 5-8 illustrate an exemplary suction container hanger assembly 200.Suction canister hanger 202 may include one or more receiving openings201A, 201B, 201C, 201D into which one or more suction canisters 906,908, 910, 912 may be placed. Openings 201A, 201B, 201C, 201D may beadapted to receive suction canisters of various sizes.

In some exemplary embodiments, receiving openings 201A, 201B, 201C, 201Dmay be arranged generally symmetrically. In some exemplary embodiments,receiving openings 201A, 201B, 201C, 201D of different sizes may beprovided and/or adjusters 216A, 216B, 216C, 216D may be adjusted toaccommodate canisters 906, 908, 910, 912 of one or more sizes and/orshapes, as best seen in FIG. 7. In an exemplary embodiment, eachadjuster 216A, 216B, 216C, 216D may be individually adjustable. In anexemplary embodiment, receiving openings 201A, 201B, 201C, 201D andtheir associated adjusters 216A, 216B, 216C, 216D may be capable ofreceiving suction canisters 906, 908, 910, 912 with diameters up toabout 6.6 inches.

Adjusters 216A, 216B, 216C, 216D may be slidable generally radiallyinward and/or outward with respect to the opening 201 (e.g., as shown byarrow A). In an exemplary embodiment, adjusters 216A, 216B, 216C, 216Dmay include a shaped end, such as curved end 218A, 218B, 218C, 218D,which may be adapted to interface with a suction canister 906, 908, 910,912. Knobs 220A, 220B, 220C, 220D may be threadedly engaged with suctioncanister hanger 202 and/or adjusters 216A, 216B, 216C, 216D to allowadjusters 216A, 216B, 216C, 216D to be secured in position relative tosuction canister hanger 202. For example knobs 220A, 220B, 220C, 220Dmay include threaded rods which may be received in correspondingthreaded openings on suction canister hanger 202. In such an exemplaryembodiment, rotation of knobs 220A, 220B, 220C, 220D may tighten knobs220A, 220B, 220C, 220D against adjusters 216A, 216B, 216C, 216D and/ormay loosen knobs 220A, 220B, 220C, 220D away from adjusters 216A, 216B,216C, 216D, thereby allowing a user to selectively secure and release anadjuster 216A, 216B, 216C, 216D for adjustment. In other exemplaryembodiments, various types of retainers known in the art may besubstituted for knobs 220A, 220B, 220C, 220D, such as other arrangementsof threaded retainers, cam-type retainers, clips, etc.

In an exemplary embodiment, adjusters 216A, 216B, 216C, 216D may beinitially positioned and secured using knobs 220A, 220B, 220C, 220D.Subsequent installation and removal of canisters 906, 908, 910, 912 maybe accomplished by lowering canisters 906, 908, 910, 912 intopre-adjusted receiving openings 201A, 201B, 201C, 201D and raisingcanisters 906, 908, 910, 912 out of pre-adjusted receiving openings201A, 201B, 201C, 201D. Adjustment of knobs 220A, 220B, 220C, 220D mayonly be necessary when a canister 906, 908, 910, 912 of a different sizeis utilized. In other exemplary embodiments, one or more adjusters 216A,216B, 216C, 216D may be adjusted more frequently during use, such aswith each canister replacement.

An exemplary suction canister hanger 202 may include a collar 203, whichmay receive pole 20 (which is shown in FIG. 2) therethrough. Suctioncanister hanger 202 may be supported by a load cell base 204, which mayinclude a housing 212 for receiving pole 20 therethrough and/or a pin214 which may extend through pole 20. Some exemplary load cell bases 204may be constructed of metal, such as steel.

In some exemplary embodiments, suction canister hanger 202 may besupported on load cell base 204 substantially by load cells 206A, 206B,206C, 206D, which may be mounted on arms 204A, 204B, 204C, 204D. Loadcells 206A, 206B, 206C, 206D may be adapted to provide electricaloutputs associated with the weight carried by the suction canisterhanger 202. In an exemplary embodiment, load cells 206A, 206B, 206C,206D may include button-type compression cells. Other exemplaryembodiments may utilize load cells of other types, such as beam-typeload cells and/or strain gauges.

In some exemplary embodiments, the total weight supported by load cells206A, 206B, 206C, 206D may be about equal to sum of the weight ofsuction canister hanger 202, the empty weights of canisters 906, 908,910, 912, and the weight of any contents of canisters 906, 908, 910,912. An exemplary embodiment may utilize signals provided by one or moreload cells 206A, 206B, 206C, 206D to determine a volume of liquidcollected in one or more suction canisters 906, 908, 910, 912 and/or todetermine when one or more suction canisters 906, 908, 910, 912 has beenreplaced.

In some exemplary embodiments, load cells 206A, 206B, 206C, 206D may bepositioned on load cell base 204 such that suction canisters 906, 908,910, 912 are located generally towards collar 203 with respect to loadcells 206A, 206B, 206C, 206D. In other words, load cells 206A, 206B,206C, 206D may be positioned radially farther from collar 203 than thecenters of mass of suction canisters 906, 908, 910, 912. Put anotherway, the centers of mass of suction canisters 906, 908, 910, 912 may bedisposed inwardly with respect to spaced-apart load cells 206A, 206B,206C, 206D. In some exemplary embodiments, load cell base 204 mayinclude three or more load cells 206A, 206B, 206C, 206D. Such anarrangement may be useful when it is desired for the sum of the loadcell readings to be representative of the total weight of the canisters906, 908, 910, 912. Further, such an arrangement may be useful whenuneven canister 906, 908, 910, 912 loading may occur.

FIG. 9 is a schematic diagram of an exemplary trumpet valve tubing set3010, which may include cartridge 410. In an exemplary embodiment,trumpet valve tubing set 3010 may include irrigation tubing 3013 andsuction tubing 3027. Irrigation tubing 3013 may include one or moreconnecters, such as spikes 3014, which may be adapted to couple with oneor more fluid containers (such as fluid bags 902, 904). Exemplary tubingsets may be provided with single or multiple spikes 3014 in variousexemplary embodiments. Irrigation tubing 3013 may include an upstreamsection 3013A, which may be fluidicly upstream of cartridge 410, and/ora downstream section 3013B, which may be fluidicly downstream ofcartridge 410.

In an exemplary embodiment, one or more clamps 3016, 3018 may beprovided downstream of the spikes 3014. Some exemplary embodiments mayinclude a Y-connector 3020 and/or other similar device joining aplurality of sections of tubing. In an exemplary embodiment, cartridge410 may be provided as part of tubing set 3010. Trumpet valve 3022 maybe fluidicly connected to cartridge 410 (e.g., via tubing 3013B) and mayinclude one or more valves for controlling flow of irrigation fluidand/or suction. Trumpet valve 3022 may include a tip 3024, which may beutilized for suction and/or irrigation. In some exemplary embodiments,tip 3024 may include electrosurgical components, such as anelectrocautery tip. An exemplary suction tubing 3027 may include asuction connection 3026, which may be coupled to a source of suction viaone or more suction containers (such as suction canisters 906, 908, 910,912), for example. In such an exemplary embodiment, the one or moresuction containers may be connected to a hospital's central suctionand/or a standalone suction device, for example.

An example trumpet valve 3022 may comprise a single-use suction andirrigation device intended for use in surgical procedures, such aslaparoscopic surgical procedures. An example trumpet valve 3022 mayinclude two push-button operated valves, one for irrigation fluid andone for suction, that may be connected to a probe attachment port. Thebody of the suction valve may include a manually adjustable false airregulator. Various probes may be attached to the probe attachment port,such as 5 mm single-lumen probes and probes including monopolar orbipolar electrosurgical tips. Some example electrosurgical probes mayinclude electrical cables that are coupleable to externalelectrosurgical generators. U.S. Pat. No. 6,234,205 describes an exampletrumpet valve and is incorporated by reference.

FIGS. 10-14 illustrate an exemplary cartridge 410 according to thepresent disclosure. Some exemplary cartridges may include a main orcenter body 410X (which may be substantially rigid) and/or one or moreside sheets 410Y, 410Z (which may be relatively flexible). An exemplarycartridge may be generally L-shaped and substantially flattened, havinga generally horizontally extending fluid IR exposure section 415 and agenerally vertically extending elevated section 417, extendingvertically up from the fluid heat transfer section 415. An exemplarycartridge 410 may include inlet and/or outlet connections, such as inletfitting 412 and outlet fitting 414 positioned at the side of thecartridge with the vertically extending elevated section 417, where theinlet fitting 412 extends generally downward and the outlet fitting 414extends generally upward from a tab section 419 extending from a side ofthe generally vertically extending elevated section 417. In an exemplaryembodiment, inlet fitting 412 and/or outlet fitting 414 may include barbfittings; however, other exemplary embodiments may utilize otherconnection devices such as compression fittings, Luer-lock fittings,glue joints, and other connection devices known in the art. In anexemplary embodiment, cartridge 410 may include additional connections,such as fitting 430, which may connect to a pressure sensor (and/or apressure transducer).

In an exemplary embodiment, cartridge 410 may include an internal flowpath through which fluid may flow from inlet fitting 412 to outletfitting 414. A front portion of an exemplary flow path is visible inFIGS. 11 and 14: lower, front fluid channel 420, port 424, port 426, andupper front fluid channel 422. In an exemplary embodiment, one or morewalls (such as wall 428) may separate various fluid channels 420, 422. Aback portion of the exemplary flow path is visible in FIG. 12: lower,back fluid channel 432, upper, back fluid channel 434 and turn section436. In an exemplary embodiment, the internal flow path may direct fluidthrough and/or past one or more bubble traps 416, 418 (which may also bereferred to as air venting chambers). In an exemplary embodiment, thebubble trap 416 nearer the inlet fitting 412 may be larger than thebubble trap 418 nearer the outlet fitting 414. In some exemplaryembodiments, a larger bubble trap 416 near the inlet fitting 412 mayremove bubbles delivered to cartridge 410 resulting from a replacementof a fluid bag 902, 904. In some circumstances, such bubbles may berelatively large. In some exemplary embodiments, a smaller bubble trap418 near the outlet fitting 414 may remove bubbles not removed by bubbletrap 416 and/or bubbles created during fluid warming within cartridge410. In some exemplary embodiments, bubble traps 416, 418 may includehydrophobic membranes 416A, 418A as described in detail below.

Fluid channels 420, 422, 432 and 434 may include generally horizontallyextending fluid channels having the following dimensions in an exampleembodiment: about 9.5″ long by about 2″ high by about 0.25″ thick. Insome example embodiments, the dimensions of fluid channels 420, 422,432, 434 may be configured to provide a substantial amount of outwardlyfacing surface area relative to the internal volume to promote efficientwarming of the fluid using IR lamps 312, 314, 316, 318.

In an exemplary embodiment, fluid may enter cartridge 410 at inletfitting 412, may flow past bubble trap 416, and into lower, front fluidchannel 420. Then, the fluid may flow through port 424 and into lower,back fluid channel 432. The fluid may generally reverse direction inturn section 436 and may flow into upper, back fluid channel 434. Turnsection 436 may include one or more ribs 436A. Fluid may then flowthrough port 426, through upper, front fluid channel 422, past bubbletrap 418, and out of cartridge 410 via outlet fitting 414. Fluidchannels 432, 434 may be separated by a horizontal wall 438. Thus, suchan exemplary embodiment may provide a three-dimensional fluid flow pathP (e.g., the fluid flow path causes the fluid to flow in the X, Y, and Zdirections), as best seen in FIG. 13.

As illustrated in FIG. 13, an elongated, three-dimensional, convolutedpath P may be defined in cartridge 410 between inlet fitting 412 andoutlet fitting 414.

Cartridge 410 may be designed such that path sections, defined by fluidchannels 420, 432, 434, and 422 are substantially aligned and/orsubstantially in registry with IR lamps 312, 318, 316, 314,respectively, when cartridge 410 is inserted into slot 310 of heaterassembly 309, as illustrated in FIG. 19.

In some exemplary embodiments, increasing the length of the fluid flowpath within the cartridge may increase the time the fluid is subjectedto heating by the IR lamps and, thereby, enable increased fluid warmingat increased fluid flow rates. A cartridge including a three-dimensionalflow path with multiple fluid channels exposed to IR lamps may enableefficient fluid warming and cost effective designs of both the cartridgeand heater assembly. A two-dimensional flow path wherein the fluid issubjected to heating by the IR lamps for the same amount of time mayresult in a larger, less cost effective cartridge and a larger, lesscost effective heater assembly and/or less efficient fluid warming.

In some exemplary embodiments, one or more fluid channels may bearranged such that they are capable of transferring heat to one or moreother fluid channels. For example, heat transfer from fluid channel 432to fluid channel 420 may occur. Similarly, heat transfer from fluidchannel 422 to fluid channel 434 may occur. Heat transfer betweenchannels may aid in dissipating heat from warmer sections, particularlyduring stagnant or low flow conditions (such as when pump 112 is notrunning). Such heat transfer may not be possible with a two-dimensionalfluid path.

A main body 410X of an exemplary cartridge 410 may be constructed ofpolycarbonate, which may be substantially rigid. In some exemplaryembodiments, the main portion of cartridge 410 may be molded as a singlepiece. In some exemplary embodiments, various fittings, such as inletfitting 412, outlet fitting 414, and fitting 430 may be integrallymolded with the main portion of the cartridge 410, while such fittingsmay be separately installed pieces in other exemplary embodiments. Insome exemplary embodiments, utilizing a single-piece molded cartridgemain body may reduce the potential for fluid leakage because of areduced number of joints. Similarly, employing integrally moldedcomponents, such as fittings 412, 414, 430 may reduce the potential forfluid leakage. In addition, integrally molded fittings (and othercomponents) may be less expensive to manufacture and may require lesslabor (e.g., they do not need to be separately installed); thus,integrally molded construction may reduce the cost of cartridge 410.

Front and/or back sides of an exemplary cartridge may be covered by oneor more sheets 410Y, 410Z of polycarbonate (such as LEXAN®polycarbonate), which may have a thickness in the range of approximately0.010-0.030 inches, for example. In an exemplary embodiment, both thefront and back sides are covered with polycarbonate sheets 410Y, 410Zhaving a thickness of approximately 0.020 inches. In an exemplaryembodiment, one or more polycarbonate sheets 410Y, 410Z may be attachedand/or sealed to the cartridge 410 using ultrasonic welding, forexample. In some exemplary embodiments, rib 436A may simplify ultrasonicwelding of polycarbonate sheets 410Y, 410Z to cartridge 410 by diffusingsome energy which may be directed generally at the projecting portion ofwall 438. The present disclosure contemplates that such polycarbonatematerials may be highly transparent to IR energy (e.g., approximately85% transmissive). Utilizing highly IR transparent materials may allow arelatively high percentage of the energy emitted by the IR lamps todirectly warm fluid within the cartridge.

In an exemplary embodiment, materials from which various components areconstructed (such as polycarbonate) may be substantially free ofpolyvinyl chloride (PVC) and/or bis(2-ethylhexyl)phthalate (DEHP). Suchmaterials may be advantageous for environmental and/or patient safetyreasons.

The present disclosure contemplates that positive displacement pumps ofvarious types may provide advantages, such as an easily calculated flowrate. The present disclosure also contemplates that, due to theirnature, certain types of positive displacement pumps may provide apulsed flow. In some exemplary embodiments, it may be desirable toprovide a non-pulsatile flow. An exemplary embodiment may include sheets410Y, 410Z, which may be somewhat flexible and/or elastic. When utilizedin connection with a pulsed fluid flow, such as that produced by someperistaltic and piston-type pumps, a cartridge 410 including one or moreflexible sheets 410Y, 410Z may operate to at least partially dampen thepulses and/or to provide more continuous fluid flow and/or pressure.

An exemplary embodiment may include a cartridge 410 and a slot 310 (see,e.g., FIGS. 3 and 15) having complementary shapes, which may preventinsertion of the cartridge 410 in slot 310 in an improper orientation.For example, an exemplary cartridge may generally have an L-shape (see,e.g., the portion of cartridge 410 including bubble trap 418), and theslot 310 may prevent full insertion of the cartridge 410 in an invertedorientation by only accommodating the L-shape in the proper orientation.An exemplary embodiment may include one or more ridges, such a upperridge 440 and/or a lower ridge 442, which may be arranged to engage oneor more corresponding grooves in slot 310. In some exemplaryembodiments, upper ridge 440 and lower ridge 442 may have differentwidths (and/or shapes), and their corresponding grooves in slot 310 maybe sized such that cartridge 410 cannot be inserted into slot 310 in aninverted orientation. Upper ridge 440 and/or lower ridge may extend atleast part of the length of cartridge 410 and/or may be discontinuous.In some exemplary embodiments, one or both of upper ridge 440 and lowerridge 442 may include an engagement feature, such as notch 410A, whichmay be used to releasably retain cartridge 410 within slot 310 of heaterassembly 309.

FIG. 14 is a detailed perspective view of a portion of an exemplarycartridge 410. An exemplary bubble trap 418 may be provided in theelevated section 417 of the cartridge and may include a plurality ofvertically extending ridges 421 and/or one or more central openings419A. The bubble trap 418 may be covered with a hydrophobic membraneadapted to vent bubbles of gas from fluid. Ridges 421 (and/or similarstructures) may provide support for the hydrophobic membrane against thefluid while allowing gas to pass through the hydrophobic membrane. Gasmay exit through openings 419A, which may be covered by a closure, suchas an umbrella valve, which may be arranged to operate as a one-wayvalve. Thus, gas may exit through openings 419A but air may be preventedfrom entering through openings 419A.

In an exemplary embodiment, at least a portion of the bubble trapcovered by the hydrophobic membrane may be canted towards the fluid sideof the membrane. Such an arrangement may increase the contact between abubble and the membrane, which may encourage the gas to pass through themembrane. More specifically, a bubble trap may include a generallyvertically oriented chamber through which fluid may flow. At least oneside of the chamber may include the hydrophobic membrane, which may beangled downwardly inward such that a rising bubble may be pressedagainst the hydrophobic membrane. The present disclosure contemplatesthat a relatively larger chamber may provide a relatively lower fluidvelocity; thus, a larger chamber may increase the probability that abubble may remain in the chamber and/or may exit through the hydrophobicmembrane, as opposed to being swept away by the fluid flow prior toexiting through the hydrophobic membrane.

In an exemplary embodiment, fitting 430 may connect to the internalfluid path of the cartridge 410 via pressure sensor fluid path 431provided in the vertical portion of the cartridge adjacent to the bubbletrap 418, which may include a hydrophobic filter 431A. Pressure sensorfluid path 431 may include a narrowed opening 431B into a verticallydisposed cavity 433, which may provide fluidic communication with fluidchannel 422. The hydrophobic filter 431A may be provided in an upperportion of the cavity 433. In such an embodiment, fitting 430 (which maybe connectable to a pressure sensing device) may convey substantiallyonly gas, and fluid may be substantially retained within cartridge 410.Because the gas may pass through hydrophobic filter 431A, the gas may beexposed to the pressure of the fluid, and the gas may transmit thepressure to the pressure-sensing device. Thus, the pressure-sensingdevice may remain dry while sensing the fluid pressure. Additionally,hydrophobic filter 431A may assist in maintaining sterility of cartridge410, such as by preventing infiltration of foreign matter into cartridge410 through fitting 430.

The present disclosure contemplates that pressure readings may becomeinaccurate if fluid comes into contact with hydrophobic filter 431A.Some exemplary embodiments may be constructed such that the volume ofgas downstream of hydrophobic filter 431A (e.g., fittings, conduits,and/or pressure sensors) and/or the volume of air upstream ofhydrophobic filter 431A (e.g., in pressure sensor fluid path 431) mayreduce the likelihood that fluid may contact hydrophobic filter 431A.For example, pressure sensor fluid path 431 may be configured to retaina volume of gas (e.g., air) in the cavity 433 sufficient to preventfluid from contacting hydrophobic filter 431A during expected pressureexcursions (e.g., the level of the fluid within pressure sensor fluidpath 431 will not rise to hydrophobic filter 431A).

Some exemplary embodiments may include one or more pressure sensorsand/or transducers fluidicly coupled to fitting 430, via heater assembly309, as shall be described in greater detail below. For example, someexemplary embodiments may include two or more pressure sensors and/ortransducers, the outputs of which may be compared. Comparisons of theoutputs of a plurality of pressure sensors may aid in the identificationof a faulty pressure sensor and/or an inaccurate pressure reading. Forexample, if pressure readings from at least two pressure sensors agreewithin an acceptable tolerance band, operation may continue. If thepressure readings from two pressure sensors differ by an amount inexcess of the acceptable tolerance band, heater assembly 309 and/or pump112 may be shut down and/or an alarm may be actuated.

FIGS. 15-19 are views of an exemplary heater assembly 309. An exemplaryheater assembly 309 may include a slot 310 for receiving cartridge 410.In some exemplary embodiments, a portion of slot 310 may be defined by aguide 334 (see, e.g., FIG. 15), which may assist a user in insertingcartridge 410 into slot 310. An exemplary embodiment may includetemperature sensors, such as IR temperature sensors 338, 340, which maybe adapted to sense the temperature of fluid within cartridge 410. Forexample, IR temperature sensors 338, 340 may detect IR energy emitted byfluid within cartridge. By ascertaining the wavelength of the emittedenergy, IR temperature sensor 338, 340 may provide an output associatedwith the temperature of the fluid adjacent the IR temperature sensor338, 340. An exemplary heater assembly 309 may also include one or moreintermediate temperature sensors as discussed below.

Some exemplary heater assemblies 309 may include a downwardly angledtrough 309C, which may be mounted generally below slot 310 and/or whichmay be configured to catch fluid leakage from cartridge 410 in slot 310.In a lower portion, the trough 309C may include a drain fitting 309Dand/or a fluid detector 2060 (such as an optical liquid detector,resistance liquid detector, continuity liquid detector, ultrasoundliquid detector, infra-red liquid detector, and the like), which mayoutput an electrical signal associated with detection of leakage fromthe cartridge. In some example embodiments, fluid detector 2060 may belocated proximate a lowest level of trough 309C. In some exemplaryembodiments, trough and/or drain fitting 309D may be sized to allowdrainage of fluid at a rate greater than would be expected in the eventof a catastrophic failure of cartridge 410 (e.g., the maximum flow ratedelivered by pump 112). In some example embodiments, detection of fluidin trough 309C by fluid detector 2060, which may indicate a leak fromcartridge 410, may result in an alarm and/or automatic shutdown of pump112 and/or heater assembly 309.

Some exemplary embodiments may include a secondary drain fitting 309F,which may be coupled to a source of vacuum to remove fluid from trough309C. More specifically, some drain fittings 309D may extend upwardsfrom the floor of trough 309C, which may prevent complete draining oftrough 309C through drain fitting 309D. Fluid detector 2060 may bemounted such that it may detect even minimal amounts of fluid withintrough 309C. Thus, secondary drain fitting 309F may be used to withdrawresidual fluid from trough 309C which may be at a level below drainfitting 309D but above fluid detector 2060.

Some exemplary heater assemblies 309 may include a blower 309A, whichmay be configured to draw cooling air through the heater assembly 309.In some exemplary embodiments, such cooling air may prevent an overtemperature condition within heater assembly 309, such as at low fluidflow rates. In some exemplary embodiments, blower 309A may be attachedto a plenum 309B, which may be connected to an upper portion of slot310, such that air may be drawn upwards past cartridge 410. Morespecifically, some heater assemblies 309 may be configured such thatblower 309A may be operative to draw air in around trough 309C, upwardthrough slot 310 past cartridge 410, through plenum 309B, and away fromheater assembly 309 through blower 309A. Some exemplary blowers 309A maybe configured to run at more than one speed and/or the speed of theblower 309A may vary with temperature (e.g., such that the airflow isincreased when the temperature is higher).

In some exemplary embodiments, temperature sensors 338, 340 may bemounted such that they detect the temperature of fluid flowing throughcartridge 410 fluidicly near inlet fitting 412 and outlet fitting 414,respectively. In an exemplary embodiment, temperature sensors 338, 340may be mounted such that they detect the temperature of fluid flowingthrough cartridge 410 prior to the fluid entering fluid channel 420 andafter the fluid exits fluid channel 422. Some exemplary temperaturesensors may be mounted such that they detect the temperature of fluid incartridge 410 at positions that are unlikely to include stagnant areas,such that the detected temperatures are representative of thetemperatures of the fluid flowing through cartridge 410. Some exemplaryembodiments may include shields, such as rings 338A, 340A, which mayreduce the effect of airflow caused by blower 309A on temperaturesdetected by temperature sensors 338, 340. Rings 338A, 340A may includetapered ramps 338B, 340B, which may assist in guiding cartridge 410 intoslot 310. In an exemplary embodiment, a temperature sensor, such as anIR temperature sensor 342, may be mounted such that it senses thetemperature of fluid in cartridge 410, such as fluid at an intermediatepoint in the internal flow path through cartridge 410. For example, IRtemperature sensor 342 may be mounted within heater assembly 309 suchthat it measures the temperature of the fluid in cartridge 410 proximateturn section 436.

An exemplary heater assembly 309 may include a fitting 336 that may befluidicly connected to fitting 430 on cartridge 410 when cartridge 410is installed in the heater assembly. Connection of fitting 430 tofitting 336 may create a sensor fluid path that connects path (chamber)431 in cartridge 410 to pressure sensors 2068, 2070, schematicallyillustrated in FIG. 18. In some exemplary embodiments, a hydrophobicfilter mounted within cartridge 410 may be utilized to prevent liquidfrom flowing through fitting 430, while allowing gas flow through thesensor fluid path.

A first set of IR lamps 312, 318 may be mounted on one side of slot 310,and a second set of IR lamps 314, 316 may be mounted on the other sideof slot 310. Thus, IR lamps 312, 318 may be directed towards one side ofcartridge 10, and IR lamps 314, 316 may be directed towards the otherside of cartridge 410. As shown in the figures, in an exampleembodiment, the IR lamps 312, 314, 316, 318 may be generally cylindricaland may have axes running generally along the horizontal direction ofthe cartridge. In some exemplary embodiments, individual IR lamps 312,314, 316, 318 may include a reflective coating (e.g., gold or aluminumoxide), such as on about 60% of the surface area so as to direct IRenergy toward cartridge 410. Some exemplary embodiments including IRlamps 312, 314, 316, 318 having reflective coatings may or may notinclude reflector shrouds 320, 322, 324, 326 running along the length ofa respective IR lamp 312, 314, 316 and 318. In some exemplaryembodiments, utilizing IR lamps 312, 314, 316, 318 with reflectivecoatings may provide improved efficiency over uncoated IR lamps 312,314, 316, 318.

In some exemplary embodiments, individual IR lamps 312, 314, 316, 318may be mounted within and/or behind protective covers, such as quartzglass tubes 312A, 314A, 316A, 318A. In some exemplary embodiments,quartz glass tubes 312A, 314A, 316A, 318A may prevent leakage of fluidfrom cartridge 410 from contacting IR lamps 312, 314, 316, 318. Someexemplary embodiments may not include quartz glass tubes 312A, 314A,316A, 318A (or other covers) and/or IR lamps 312, 314, 316, 318 may besubstantially directly exposed to cartridge 410, which may increasefluid warming efficiency.

The present disclosure contemplates that an ellipse includes two foci,and that rays emitted by a source at one of the foci are reflected tothe other foci. In an exemplary embodiment, one or more reflectorshrouds 320, 322, 324, 326 may include at least a partial substantiallyelliptical shape (in cross section) with an IR lamp 312, 314, 316, 318located at or near one of the foci and with a portion of cartridge 410located at or near the other foci. Accordingly, IR energy emitted by theIR lamp 312, 314, 316, 318 may be reflected to the portion of thecartridge 410. For example, reflector 324 and cartridge 410 may bearranged in relation to an ellipse 3320 and its two foci 3321, 3322. Inan exemplary embodiment, IR lamp 316 may be located at or near foci 3321and/or fluid channel 434 is located at or near foci 3322. One or more ofreflector shrouds 320, 322, 324, 326 may have a similar arrangement.

In an exemplary embodiment, one or more reflector shrouds 320, 322, 324,326 may be arranged to direct IR energy at particular locations oncartridge 410 and to limit the amount of IR energy directed at otherlocations on cartridge 410. For example, one or more reflector shrouds320, 322, 324, 326 may be arranged to limit the IR energy directed atportions of cartridge 410 where limited IR exposure may be desired. Forexample, limited IR exposure may be desired for portions of cartridge410 including little or no fluid and/or portions that are notsubstantially transparent to IR energy. For example, reflector shrouds320, 322, 324, 326 may be arranged to limit the IR energy directed atvarious seams and/or welds. In some exemplary embodiments, such use ofreflector shrouds 320, 322, 324, 326 may obviate a need to employ acartridge 410 including substantially reflective portions to preventabsorption of IR energy in undesired locations. In some exemplaryembodiments, directing a greater proportion of the IR energy towardsdesired positions on the cartridge 410 may increase the efficiency ofthe device.

In some exemplary embodiments, reflector shrouds including other shapesmay be employed. For example, a reflector shroud having a parabolicshape in cross-section may be utilized, and an IR lamp may be locatedapproximately at the focal point of the parabola, and the IR energy maybe directed towards at least a portion of a cartridge. In some exemplaryembodiments, parabolic reflector shrouds may obviate a need to employ acartridge 410 including substantially reflective portions to preventabsorption of IR energy in undesired locations (such as seams and/orwelds). In some exemplary embodiments, directing a greater proportion ofthe IR energy towards desired positions on the cartridge 410 mayincrease the efficiency of the device.

In an exemplary embodiment, reflector shrouds 320, 322, 324, 326 may beconstructed from aluminum and/or another reflective material. In someexemplary embodiments, reflector shrouds 320, 322, 324, 326 may includea polished surface. For example, reflector shrouds 320, 322, 324, 326may be constructed of aluminum and may include polished surfaces. Insome exemplary embodiments, reflector shrouds 320, 322, 324, 326 may beplated or otherwise coated with a reflective material (such as gold oraluminum oxide). For example, a steel reflector may include agold-plated reflective surface.

In some exemplary embodiments, heater assembly 309 may include one ormore engagement features, such as ball detent 310A. Ball detent 310A mayreleasably engage notch 410A of rib 440, thereby releasably retainingcartridge 410 in slot 310. Some exemplary embodiments may include one ormore cartridge switches 2046, which may open or shut when a cartridge410 is fully installed in slot 310.

FIG. 20 is a schematic diagram of an exemplary power and control system8 for an exemplary fluid management system 10. It is to be understoodthat some exemplary embodiments may include various appropriate powersupplies, circuit breakers, fuses, terminal boards, and the like, aswould be apparent to one of skill in the art.

In an exemplary embodiment, electrical power may be supplied to a fluidmanagement system 10 via a detachable power cord 2010, a line filter2012, and appropriate fuses and/or circuit breakers. One or more powersupply units may provide appropriate voltages and currents to thevarious electrical loads. In some exemplary embodiments, some componentsmay receive power from more than one power supply. For example, acomponent utilizing two voltages may receive power from two powersupplies.

An exemplary embodiment may include one or more fans and/or blowers(such as blower 309A and/or chassis fan 2018), one or more IR lamps 312,314, 316, 318 (IR lamps 312, 314 may comprise a first group 313, and IRlamps 316, 318 may comprise a second group 317), a pump motor 2042associated with pump 112, a printer 111, an isolation board 2034, and/orone or more remote display devices 2038 (such as a liquid crystaldisplay, LED display, organic light-emitting diode display, and thelike). For example, secondary display 106A may include a remote display2038. Relays 2020, 2021, 2040 may selectively supply power to one ormore components.

An exemplary isolation board 2034 may provide control signals to one ormore solid state relays 2076, 2078, which may selectively supply powerto IR lamps 312, 314, 316, 318, and/or controller 2074, which may beoperatively coupled to pump motor 2042. In an exemplary embodiment,isolation board 2034 may include one or more digital-to-analog (D/A)converters which may supply an analog control signal (such as a 0-5Vcontrol signal for controller 2074). Isolation board 2034 may operate toisolate high voltages supplied to certain components (e.g., pump motor2042 and/or IR lamps 312, 314, 316, 318), which may improve patientsafety.

An exemplary embodiment may include one or more interlocks associatedwith certain conditions that may be operative to allow or preventoperation of various components of a fluid management unit 100. Forexample, a door switch 2044 may open if door 108 is opened, therebycutting off power to IR lamps 312, 314, 316, 318 and/or pump motor 2042via relays 2020, 2021, 2040. In some exemplary embodiments, door 108 maynot be fully shut unless the cartridge 410 is properly installed, thetubing set is properly installed, and/or the pump head is properly shut.Thus, door 108 may function as a primary safety device by only allowingdoor switch 2044 to shut when these conditions are satisfied. In anexemplary embodiment, switch 2044 may be integrated with one or more oflatch component 118 and corresponding latch component 120.

In an exemplary embodiment, a cartridge switch 2046 may shut when acartridge 410 is fully inserted into heater assembly 309, therebyallowing relays 2020, 2021, 2040 to supply power to IR lamps 312, 314,316, 318 and/or pump motor 2042. It is to be understood that in someexemplary embodiments, one or more switches 2044, 2046 may be configuredto open when a condition is satisfied. In an exemplary embodiment,thermal cut off sensor(s) 2048 may open when a predetermined fluidtemperature is exceeded, which may cause the cutting off of power to IRlamps 312, 314, 316, 318 and/or pump motor 2042.

An exemplary embodiment may include a main processor 2050, which mayperform various functions (such as computing, calculation, control,interface, display, logging, and the like). Main processor 2050 may beoperatively connected to one or more user interface components, such astouch screen 106 and/or remote display device 2038. An exemplary mainprocessor 2050 may be operatively connected to one or more speakers 2052and/or one or more universal serial bus (“USB”) devices 2054 via one ormore USB interfaces 2056. In an exemplary embodiment, data such as datapertaining to operations of the device and/or software updates may betransferred via the USB interface 2056, for example.

Some exemplary embodiments may provide network communicationcapabilities, such as by including an Ethernet port 2056A through whichthe device may be connected to a network, such as a local area network.Data transfer for any purpose may be accomplished via the network, suchas providing software updates, transferring data pertaining tooperations of the device, and/or transmitting error codes, for example.

An exemplary embodiment may include an input/output (I/O) board 2058which may be operatively connected to main processor 2050 and/or whichmay receive signals from one or more sensors, such as IR temperaturesensors 338, 340, 342. I/O board 2058 may be operatively connected toone or more switches associated with certain conditions, such as bubbledetector 132 and/or leakage detector 2060, which may be associated withtrough 309C. I/O board 2058 may receive signals from one or moresensors, such as load cells 142, 144, 206A, 206B, 206C, 206D and/orpressure sensors 2068, 2070.

Some exemplary embodiments may include various safety switches, such ascabinet over-temperature switch 2062A (which may detect a hightemperature condition in fluid management unit 100), current sensor2062B (which may sense whether electrical current is flowing to IR lamps312, 314, 316, 318), blower-on switch 2062C (which may sense whetherblower 309A is running), canister connected switch 2062D (which maysense whether suction container hanger assembly 200 is present), and/orfan-on switch 2062E (which may sense whether chassis fan 2018 isrunning).

In some exemplary embodiments, fluid management unit 100 may be userselectable between a pressure control mode and a flow control mode. Inan exemplary pressure control mode, pump 112 may be controlled (e.g.,started, stopped, and its speed adjusted) to maintain a fluid pressuredelivered to a surgical site at about a target pressure and/or within apredetermined pressure band. In an exemplary flow control mode, pump 112may be controlled (e.g., started, stopped, and its speed adjusted) todeliver fluid to a surgical site at a about target flow rate and/orwithin a predetermined flow rate band. In both pressure and flow controlmodes, heater assembly 309 may be controlled (e.g., IR lamps 312, 314,316, 318 may be energized, deenergized, and/or the power level suppliedto IR lamps 312, 314, 316, 318 may be adjusted) to maintain thetemperature of the fluid delivered to the surgical site at about atarget temperature and/or within a predetermined temperature band if thefluid warming feature has been enabled by the user.

FIG. 21 is a schematic diagram of an exemplary equipment setup utilizingmulti-stage heating. In an exemplary embodiment, one or more of IR lamps312, 314, 316, 318 may be controlled in association with one or moreothers of IR lamps 312, 314, 316, 318. For example, IR lamps 312, 314may comprise a first group 313, and IR lamps 316, 318 may comprise asecond group 317. In an exemplary embodiment, fluid may flow past the IRlamps associated with one group prior to flowing past the IR lampsassociated with a second group, and the first and second groups may becontrolled independently. For example, the fluid flow path in cartridge410 including channels 420, 432, 434, 422 (in that order) may directfluid past lamps 312, 314, 316, 318 (in that order).

In an exemplary embodiment, the first group 313 may be control based atleast in part on a sensed inlet temperature (such as sensed bytemperature sensor 338), and the second group 317 may be controlledbased at least in part on a sensed temperature of the fluid between thefirst and second groups, which may be referred to as a midpointtemperature (such as sensed by temperature sensor 342), and/or a sensedoutlet temperature (such as sensed by temperature sensor 340). An outlettemperature, which may be the temperature of the fluid after it haspassed the second group (such as sensed by temperature sensor 340), mayalso be used to vary one or more power scaling factors associated withthe power applied to one or more groups of IR lamps.

In some exemplary embodiments, the amount of power applied to one ormore stages (e.g., groups 313, 317) may be based at least partially on aflow rate of fluid through heater assembly 309. In some exemplaryembodiments, a flow rate may be determined using a known flow rate perrotation of the pump 112 and the rotational speed of the pump 112, forexample. In some other exemplary embodiments including other types ofpositive displacement pumps, the flow rate may be determined in asimilar manner. In some exemplary embodiments, a flow rate sensor may beutilized to measure a flow rate.

Some exemplary embodiments may be configured to account for one or moreof the following conditions: variations in incoming fluid temperatureduring a procedure, variations in flow rate to maintain constantpressure, changes to temperature set point by the user, interruptionsand/or changes in flow rate during a procedure caused by opening/closingof external valves (e.g., trumpet valves, valves in surgicalinstruments, etc.), and/or resuming warming when stopped flow resumes.

In some exemplary embodiments, the first group 313 may be powered basedat least in part upon an estimated power requirement, which may bedirectly proportional to a total desired temperature change of the fluid(e.g., outlet temperature minus inlet temperature) and/or a flow rate ofthe fluid. In some example embodiments, the estimated power requirementmay be multiplied by a load factor, which may determine a fraction ofthe estimate power that is to be delivered to the first group. In someexemplary embodiments, the first group may be deenergized whenever pump112 is stopped.

In some exemplary embodiments, the second group 317 may be powered basedat least in part upon a proportional control algorithm and/or anintegral control algorithm. In an example proportional controlalgorithm, the estimated power may be multiplied by a proportionalfactor whose value varies with the temperature error (desired outlettemperature−current outlet temperature). For example, the proportionalfactor may be given by

$1.1 + {\frac{{temperature\_ error}^{2}}{400}.}$

In some exemplary embodiments, the constants may be selected such thatthe desired outlet temperature may be achieved reasonably quickly withlimited overshoot. In addition, some constants may be selected to atleast partially compensate for older lamps that may have begun toexhibit performance degradation. In an exemplary embodiment, the valueof 1.1 results in a power at the desired outlet temperature that isabout 10% above the estimated power. In an exemplary embodiment, thevalue of 400 (20²) may be based on the notion that an expected initialerror may be on the order of 20° C. which would result in proportionalfactor of 2.1.

In an example integral control algorithm, the power applied to thesecond group 317 may be adjusted in small increments (e.g., about 1% perincrement) based on the integral of the temperature error. For example,if the integral of the temperature error is less than a predeterminednegative value (e.g., fluid temperature is high), the power applied tothe second group may be reduced by one increment. Similarly, if theintegral of the temperature error is greater than a predeterminedpositive value (e.g., fluid temperature is low), the power applied tothe second group 317 may be increased by one increment. Thepredetermined negative value and the predetermined positive value mayvary based at least in part upon the flow rate of the fluid.

Some example embodiments may provide a pressure curve override, whichmay reduce heating when the pump 112 is running but little or no fluidis flowing. For example, if the irrigation valve on a trumpet valve israpidly shut, pump 112 may continue to run until the fluid reaches apredetermined maximum pressure. In such a situation, it may be desirableto reduce the power supplied to the second group 317, or to deenergizethe second group entirely. For example, if the sensed pressure increasesat a rate in excess of 2 mmHg/second, the second group 317 may bedeenergized.

Algorithm selection may be based at least in part upon the currentdeviation from the desired outlet temperature. For example, when thecurrent outlet temperature is substantially below the desired outlettemperature, the proportional control algorithm may be used. As thecurrent outlet temperature approaches the desired outlet temperature,integral control may be used. At some temperature deviations, a powerreduction factor may be applied to reduce the power supplied to thesecond group 317 to prevent overshooting the desired outlet temperature.In some exemplary embodiments, the power reduction factor may vary fromabout 1.0 (no reduction) down to about 0 (no power applied) as thecurrent outlet temperature reaches and/or exceeds the desired outlettemperature.

In an exemplary embodiment, pulse width modulation may be employed tovary the power applied to one or more IR lamps 312, 314, 316, 318. Forexample, processor 2050, via I/O board 2058 and/or isolation board 2034,may direct SSRs 2076, 2078 to selectively energize and deenergize firstgroup 313 and/or second group 317. The duty cycle (e.g., the ratio of ontime to the sum of the on and off times in an on/off cycle) may bevaried to deliver more or less power to the first group 313 and/orsecond group 317 as desired. More specifically, if it is desired toincrease the amount of power delivered to first group 313, the firstgroup's duty cycle may be adjusted by causing SSR 2076 to increase theon time and reduce the off time in each on/off cycle. Similarly, if itis desired to reduce the amount of power delivered to the second group317, the second group's duty cycle may be adjusted by causing SSR 2078to reduce the on time and increase the off time in each on/off cycle.

Some exemplary embodiments may utilize pressure control modes fordistention applications, and some pressure control modes may be referredto as distention modes although the fluid is likely being used for bothdistention (body cavity expansion) and irrigation (blood and debrisremoval) purposes. Some exemplary embodiments may utilize flow controlmodes for irrigation applications, and some flow control modes may bereferred to as irrigation modes.

FIG. 22 is a schematic diagram of an exemplary equipment setup for usewith a trumpet valve. In an exemplary embodiment, irrigation tubing 3013may extend through pump 112 such that pump 112 is operative topressurize and/or propel liquid in irrigation tubing 3013.

FIG. 23 is a schematic diagram of an exemplary equipment setup for usewith an electrosurgical device. In some exemplary embodiments, anelectrosurgical tip 3024 may receive electrical power from an externalpower source 3036, such as an electrosurgical generator.

FIG. 24 is a schematic diagram of an exemplary equipment setup for usewith a tubing set including one or more connectors 3028, 3030 forconnection to one or more surgical instruments 3032. For example, Luerconnectors may be provided. Exemplary surgical instruments which may beutilized with exemplary fluid management units 100 may includearthroscopes, hysteroscopes, and/or cystoscopes, and the like. Similardevices may be employed in other procedures, such as transurethralresection of the prostate (TURP). The present disclosure contemplatesthat other surgical instruments known in the art may be utilized inconnection with various exemplary embodiments.

Any tubing set and/or equipment setup used in connection with exemplaryfluid management units 100 according to the present disclosure mayinclude one or more relief valves. For example, one or more reliefvalves 3013R may be fluidicly connected in and/or to irrigation line3013 downstream of pump 112. In such embodiments, if the fluid pressuredownstream of pump 112 exceeds the set pressure of the relief valve3013R for any reason, including a failure in fluid management system100, the relief valve 3013R may discharge fluid until the fluid pressurefalls below the re-seat pressure of the relief valve 3013R. Such apressure relief valve 3013R may be completely independent of themicroprocessor-based control system for fluid management unit 100 and,therefore, may comprise a substantially redundant safety mechanism.

Some exemplary embodiments may include one or more remote pressuresensors 2069A. For example, a remote pressure sensor 2069A may be placedat least partially in a body cavity 3052A being distended, such as auterus or a bladder, and such remote pressure sensor 2069A may provide apressure signal to fluid management unit 100. For example, a remotepressure sensor 2069A located in a body cavity being distended mayprovide an electrical (e.g., analog and/or digital) and/or pneumaticsignal indicative of fluid pressure within the cavity. Such analog,digital, and/or pneumatic signal may be conveyed to fluid managementunit 100 directly and/or via the heating cartridge 410. Fluid managementunit 100 may use such signal from remote pressure sensor 2069Aindicating fluid pressure in the body cavity 3052A being distended inplace of, or in addition to, the signal indicating fluid pressure incartridge 410 to control fluid pressure at the desired level selected bythe user and, if necessary, to trigger alarms or shut down the pump 112to prevent unsafe conditions.

FIG. 25 is a schematic diagram of an exemplary equipment setup forinfusion. Such a device may be utilized with any fluids to be infusedinto a patient, including pharmaceuticals and/or blood components. Someexemplary embodiments may include one or more bubble detectors 132 (FIG.2) within unit 100 and/or one more bubble detectors 3050 external tofluid management unit 100. In some exemplary embodiments, the fluid maybe gravity fed, and the tubing may bypass pump 112. In some exemplaryembodiments, an in-line filter 3051 may be employed, such as when bloodis being infused. Such tubing sets used for infusion may also include apressure relief valve 3013R to reduce the likelihood of infusing fluidsinto a patient at excess pressures for any reason, including a failureof fluid management system 100.

FIGS. 26 and 27 illustrate an alternative example cartridge 2410.Cartridge 2410 may be generally similar to cartridge 410, except thatcartridge 2410 may include a two-dimensional fluid flow path.Specifically, in some example embodiments, fluid may enter cartridge2410 at an inlet fitting which may be generally similar to inlet fitting412, may flow past bubble trap 2416, and into lower fluid channel 2420.Then, fluid may generally reverse direction in turn section 2436 and mayflow into upper fluid channel 2434. Fluid may then flow past bubble trap2418 and out of cartridge 2410 via an outlet fitting which may begenerally similar to outlet fitting 414. Cartridge 2410 may include anyother features discussed herein with reference to cartridge 410, such asfitting 2430.

Some example cartridges 2410 may comprise two sections 2410A, 2410B,which may be joined together using adhesive, solvent bonding, ultrasonicbonding, and/or RF welding, or the like. Sections 2410A, 2410B may beconstructed by vacuum forming thin plastic to form the desired features.Unlike cartridge 410, some exemplary cartridges 2410 may not include asubstantially rigid center section. In some exemplary embodiments, onesection (e.g., section 2410A) may be flat and/or flatter than anothersection (e.g., 2410B). For example, certain fluid flow paths and/orfluid channels (lower fluid channel 2420 and/or upper fluid channel2434) may be formed in one section (e.g., section 2410B) while at leastsome of the other section (e.g., section 2410A) may be substantiallyflat and/or configured to lie against section 2410B to form certainfeatures.

An example cartridge 2410 may be configured for use in connection withheater assembly 309 described herein. Accordingly, fluid withincartridge 2410 may be warmed by IR lamps 312, 314, 316, 318. In someexample embodiments, lower fluid channel 2420 may be warmed from oneside by IR lamp 312 and from the opposite side by IR lamp 314.Similarly, upper fluid channel 2434 may be warmed from one side by IRlamp 318 and from the opposite side by IR lamp 316.

FIG. 28 illustrates an alternative example cartridge 1410. Similar tocartridge 2410 described above, some example cartridges 1410 maycomprise two sections 1410A, 1410B. In some exemplary embodiments,section 1410A may include bubble traps 1416, 1418, which may begenerally similar to bubble traps 416, 418 described above. In someexemplary embodiments, cartridge 1410 may include one or more fluidchannels 1422 to which fluid may be supplied to or discharged from viaone or more fluid conduits 1422A. Some exemplary fluid conduits 1422Amay be formed in one or more of sections 1410A, 1410B in a mannersimilar to fluid channel 1422. In some exemplary embodiments, fluid mayenter cartridge 1410 through in inlet fitting generally similar to inletfitting 412, flow through bubble trap 1416, flow through fluid conduit1422A, flow through fluid channel 1422, flow through bubble trap 1418,and/or may exit cartridge 1410 via an outlet fitting generally similarto outlet fitting 414. Some exemplary cartridges 1410 may include apressure tap and/or fluid path generally similar to those of cartridge410.

In some exemplary embodiments, only one or more IR lamps 312, 314, 316,318 may be used in connection with cartridge 1410. For example, upperlamps 316, 318 may be used in connection with cartridge 1410, whilelower lamps 312, 314 may remain deenergized. Some exemplary fluidmanagement units 100 may be configured for such operations by entry of apart number corresponding to the cartridge type by a user.

Some exemplary cartridges 1410 may have a lower internal volume thatcartridge 410 described above, which may utilize a smaller volume offluid for priming than cartridge 410. Some exemplary cartridges 1410 mayprovide relatively lower fluid flow rates than some exemplary cartridges410. Thus, some exemplary cartridges 1410 may be used in place of someexemplary cartridges 410 in some procedures in which lower fluid flowrates may be expected.

Some exemplary embodiments may include a remote control device, such asa pneumatic remote control device. For example, a pneumatic signal maybe produced by a pneumatic actuator (such as a bulb, button, bellows,piston, or the like), which may be mounted near or on, or integratedwith a hand piece and/or surgical instrument. The pneumatic signal maybe conveyed to the fluid management unit 100. For example, a thepneumatic signal may be conveyed via tubing extending from the pneumaticactuator to a fitting on a cartridge, through a passage in thecartridge, and to a pressure transducer (or other device capable ofproducing an electrical signal based at least partially upon thepneumatic signal) via a fitting which releasably engages a correspondingfitting in heater assembly 309. As another example, a pneumatic signalmay be conveyed via tubing extending from the pneumatic actuator, to afitting on fluid management unit 100, and to a pressure transducer (orother device capable of producing an electrical signal based at leastpartially upon the pneumatic signal). The pneumatic signal may beutilized to cause an adjustment in a desired pressure, flow rate, orother operating parameter, for example. Such an adjustment may be amomentary or a sustained incremental adjustment, for example.

Some exemplary embodiments may provide a perforation alarm, which may beparticularly useful in hysteroscopic procedures and the like, forexample. An exemplary perforation alarm may be based on an increasedrate of change of the deficit. For example, an alarm may be triggeredwhen the deficit is increasing at a rate in excess of 200 mL/min. Inexemplary embodiments, the set point of one or more perforation alarmsmay be programmed by a user.

Some exemplary embodiments may be capable of warming fluids from astorage temperature to an appropriate temperature for use withoutpre-warming in a warming cabinet, for example.

Some exemplary embodiments may include a user interface allowing a userto specify a particular type of tubing set that is being utilized. Insome exemplary embodiments, the device may automatically determine aparticular type of tubing set that is being installed by, for example,using one or more bar codes (or other optical codes), radio-frequencyidentification (RFID) transponders, color-coding, and the like. In someexemplary embodiments, default parameters may be automatically set basedupon a sensed tubing set type.

Some exemplary embodiments may include a user-configurable interface,which may be provided using touch screen 106. In exemplary embodiments,user may be able to specify the data (such as temperature, pressure,flow rate, deficit, etc.) that are displayed, and may be able specify amanner of display (e.g., numeric value, graphical representation of asingle value or a value over time, etc.). In some exemplary embodiments,the user interface may be adapted to provide instructions (such asstartup instructions, cleaning instructions, and/or operatinginstructions) to a user via touch screen 106, for example. In someexemplary embodiments, a language used on a display may beuser-selectable. In some exemplary embodiments, the touch screeninterface may be configured to display error codes, conditions, and/ordescriptions and may also be configured to display preventativemaintenance notifications.

FIGS. 29-40 are screen shots of an exemplary touch screen 106. Thesescreen shots are described with reference to “buttons,” which maycomprise portions of touch screen 106 configured to appear like buttonsand/or which may provide functionality similar to physical buttons. FIG.29 illustrates an example setup screen, which may include a setup button4002, a supervisor mode button 4004, and/or a date/time display 4006.Setup button 4002 may be used to initiate setup of fluid management unit100 for a procedure, supervisor mode button 4004 may be used to enter asupervisor mode (which is discussed in detail below), and/or the dateand/or time may be adjusted using date/time display 4006.

FIG. 30 illustrates an exemplary tubing set selection screen, which mayinclude setup instructions 4008, a tubing set list 4010, and/or acontinue button 4012. Tubing set list 4010 (which may include one ormore tubing set types) and/or continue button 4012 may be used tospecify a particular type of tubing set that will be used.

FIG. 31 illustrates an exemplary surgical discipline selection screen,which may include a discipline list 4014, a continue button 4016, and/ora back button 4018. Discipline list 4014 (which may include one or moresurgical disciplines) and/or continue button 4016 may be used to specifya surgical discipline associated with a desired procedure. Disciplinelist 4014 may be automatically populated based at least in part upon thepreviously selected type of tubing set. Back button 4018 may return theuser to the tubing set selection screen.

FIG. 32 illustrates an exemplary procedure selection screen, which mayinclude a procedure list 4020, a continue button 4022, and/or a backbutton 4024. Procedure list 4020 (which may include one or moreprocedures) and/or continue button 4022 may be used to specify a desiredsurgical procedure. Procedure list 4020 may be automatically populatedbased at least in part upon the previously selected type of tubing setand/or the previously selected surgical discipline. Back button 4024 mayreturn the user to the discipline selection screen.

FIG. 33 illustrates an exemplary physician selection screen, which mayinclude a physician list 4026, an add button 4028, a delete button 4030,a move up button 4032, a move down button 4034, an edit button 4036, acontinue button 4038, and/or a back button 4040. Physician list 4026(which may include one or more physicians) and/or continue button 4038may be used to specify a physician. Physician names may be added to,deleted from, or reordered on physician list 4026 using the add button4028, the delete button 4030, the move up button 4032, and/or the movedown button 4034. Back button 4040 may return the user to the procedureselection screen.

FIG. 34 illustrates an exemplary operator selection screen, which mayinclude an operator list 4042, an add button 4044, a delete button 4046,a move up button 4048, a move down button 4050, an edit button 4052, acontinue button 4054, and/or a back button 4056. Operator list 4042(which may include one or more operators) and/or continue button 4054may be used to specify a operator. Operator names may be added to,deleted from, or reordered on operator list 4042 using the add button4044, the delete button 4046, the move up button 4048, and/or the movedown button 4050. Back button 4056 may return the user to the procedureselection screen.

FIG. 35 illustrates an exemplary control mode selection screen. Pressuremode button 4058 and/or flow mode button 4060 may allow toggling betweena pressure control mode and a flow control mode. Option buttons, such asdeficit monitoring button 4062 and/or heater button 4064 may allowselection of optional functions. Continue button 4066 may advance theinterface to the next screen. In some exemplary embodiments, the controlmode (e.g., pressure or flow) and/or optional functions may be selectedby default based at least in part upon previously entered information.For example, if the entered discipline and procedure utilize pressuremode, the system may assume that pressure mode, deficit monitoring,and/or heater should be enabled. Similarly, if the entered disciplineand procedure utilize flow mode, the system may assume that flow modeand/or heater should be enabled and/or that deficit monitoring should bedisabled. These defaults may be accepted by pressing the continue button4066, or the settings may be adjusted as desired prior to pressing thecontinue button 4066.

FIG. 36 illustrates an exemplary priming screen, which may includepriming instructions 4068, and automatic prime button 4070, a manualprime button 4072, a remote button indicator button 4074, a continuebutton 4076, and a flow rate indicator 4078. In some exemplaryembodiments, the automatic prime button 4070 may cause pump 112 to runfor a predetermined time sufficient to prime tubing set assuming theuser has opened the irrigation valve on the trumpet valve or surgicalinstrument to vent air that would otherwise be trapped in the tubingset, where the predetermined time may vary based upon the tubing settype selected previously. In some exemplary embodiments, the manualprime button 4072 may cause pump 112 to run while it is depressed andpump 112 may stop running when it is released. Manual prime button 4072may be depressed until fluid has substantially filled the tubing set. Insome exemplary embodiments, flow rate indicator may display the currentflow rate of fluid.

FIG. 37 illustrates an exemplary secondary display and printer controlscreen. A secondary display control box 4080 may allow a user to selectparameters that will be displayed on secondary display 106A, such astemperature, pressure, volume, and/or deficit. A printer control box4082 may display information related to printer 111 (e.g., whetherprinter 111 is out of paper) and/or may allow a user to selectinformation to be printed at the end of a procedure (e.g., temperature,pressure, volume, deficit, and the like). Continue button 4084 may beused to advance to the next screen.

FIG. 38 illustrates an exemplary run screen for a procedure requiringfluid pressure control, which may include a temperature section 4086, apressure section 4088, a deficit monitoring section 4090, a flow section4092, a fluid remaining indicator 4094 (which may indicate anapproximate amount of fluid remaining in fluid bag 902), a fluidremaining indicator 4096 (which may indicate an approximate amount offluid remaining in fluid bag 904), a start/stop button 4098, an endprocedure button 5000, and/or a back button 5002. An exemplarytemperature section 4086 may include current temperature 5004, setpointtemperature 5006 (e.g., target temperature), temperature alarm setpoint5008, and/or temperature alarm action settings 5010 (e.g., what actions,in addition to a visual alarm, will automatically be taken uponactuation of the temperature alarm, such as sounding an audio alarmand/or stopping fluid flow). An exemplary pressure section 4088 mayinclude current pressure 5012, setpoint pressure 5014 (e.g., a targetpressure), pressure alarm setpoint 5016, pressure alarm action settings5018 (e.g., what actions, which may be in addition to a visual alarm,will automatically be taken upon actuation of the pressure alarm, suchas sounding an audio alarm and/or stopping flow), and/or a flow limit5020 (e.g., a maximum allowable flow rate). An exemplary deficitmonitoring section 4090 may include current deficit 5022, deficit alarmlimit 5024, perforation alarm limit 5026, and/or perforation alarmaction settings 5028 (e.g., what actions will automatically be takenupon actuation of the perforation alarm, such as sounding an audio alarmand/or stopping flow). Start/stop button 4098 may be used to startand/or stop the fluid management unit 100 without terminating theprocedure, the end procedure button 5000 may be used to terminate theprocedure, and/or back button 5002 may be used to return to thesecondary display and printer control screen.

In some exemplary fluid pressure control embodiments, default operatingparameters (e.g., one or more of setpoint temperature 5006, temperaturealarm setpoint 5008, temperature alarm action settings 5010, setpointpressure 5014, pressure alarm setpoint 5016, pressure alarm actionsettings 5018, flow limit 5020, deficit alarm limit 5024, perforationalarm limit 5026, and/or perforation alarm action settings 5028) may beset based at least in part upon the selected discipline and/or selectedprocedure. In some exemplary embodiments, these operating parameters maybe adjusted by touching the corresponding portion of the touch screen106. Some exemplary embodiments may allow adjustment of these operatingparameters up to predetermined maximum limits, which may be associatedwith safety considerations. If a condition exceeds an operatingparameter when the operating parameter is below its respective maximumlimit, the resulting alarm may be overridden and operation may continueprovided that the maximum limit is not reached. Some exemplaryembodiments may stop operation upon reaching a maximum limit, which maynot be overridden.

FIG. 39 illustrates an exemplary summary screen, which may displayprocedure information 5030. A print button 5032 may cause printer 111 toprint the procedure information 5030. A new procedure button 5034 mayreturn the user to the setup screen described above to prepare fluidmanagement unit 100 for use in a new procedure.

FIG. 40 illustrates an exemplary supervisor screen, which may include aninput type selection section 5036. Input type selection section 5036 mayallow a supervisor to select information that will be gathered duringthe setup process. For example, physician and/or operator identities maybe gathered as described above. Similarly, patient identifyinginformation and/or other information may be gathered in a similarfashion. An exemplary supervisor screen may allow a supervisor toperform other functions, such as calibrating one or more of load cells142, 144, 206A, 206B, 206C, 206D via calibrate button 5038, resetting apassword via password reset button 5040, and/or importing or exportingdata via import/export button 5042.

An exemplary embodiment may be operated as follows. An operator may hangone or more fluid bags 902, 904 on one or more of fluid bag hangers 102,104. The operator may install one or more suction canisters 906, 908,910, 912 into suction canister hanger 202. The operator may connect atubing set (e.g., trumpet valve tubing set 3010) to the fluid bags 902,904, load a section of tubing into pump 112, load cartridge 410 intoheater assembly 309, load a section of irrigation tubing 3013 into path124, connect suction tubing 3027 to one or more suction canisters 906,908, 910, 912 and shut door 108. The operator may then utilize touchscreen 106 to set up the fluid management unit 100, which may includeselecting the tubing set, a surgical discipline, procedure type, setpoint fluid temperature, set point fluid pressure (in pressure controlmode), set point fluid flow rate (in flow control), and/or otherparameters (such as display content and/or arrangement, alarm set pointsand/or indications, and the like).

An exemplary embodiment may be operated in a pressure control mode. Thepressure of the fluid may be sensed via a tap (which may be a fluidconnection) in fluid communication with the fluid flow path (such asfitting 430) and/or via a pressure sensor located at or in the surgicalsite (e.g., remote pressure sensor 2069A). In an exemplary embodimentwhere the fluid is sensed via a tap in fluid communication with thefluid flow path, the pressure of the fluid may be sensed by more thanone pressure sensor 2068, 2070 for redundancy purposes.

An exemplary pressure control mode may be configured to pump fluid atabout a flow rate that establishes and maintains the pressure within anacceptable range corresponding to the set point established by the user.In an exemplary embodiment, the manner in which pressure is controlledis determined may be based at least in part on the relationship ofactual pressure to the set point pressure. Accordingly, the system maydetermine if actual pressure is in Zone 0 (which may be defined asactual pressure between 0 and the pressure at the lowest value of theset point tolerance band which may be referred to as Low ToleranceLevel), Zone 1 (which may be defined as actual pressure between the LowTolerance Level and the desired pressure level which may be referred toas Set Point Level), Zone 2 (which may be defined as actual pressurebetween the Set Point Level and the pressure at the highest value of theset point tolerance band which may be referred to as High ToleranceLevel), Zone 3 (which may be defined as actual pressure between the HighTolerance Level and the pressure level that triggers alarms which may bereferred to as the Alarm Level), and/or Zone 4 (which may be defined aspressure exceeding the Alarm Level).

Some example fluid management units 100 may be configured to employmultiple modes of pressure control. In an exemplary Slope mode, thedesired minimum slope of pressure (rate of pressure increase) may becalculated and the fluid flow rate may be adjusted at least in partbased on the actual slope of the pressure increase. In an exemplaryControl mode, the fluid flow rate may be adjusted incrementally (e.g.,by about ±1 ml/min) based at least in part upon a sum of errorsmethodology. For example, an integral Control mode may includecalculating an integral of a pressure error (e.g., set pointpressure−actual pressure) over time and adjusting operation of the pump112 to incrementally adjust a fluid flow rate based at least in partupon the integral of the pressure error. In an exemplary Coast mode,pump speed may be substantially maintained. In an exemplary Reductionmode, the fluid flow rate may be monitored and left substantiallyunchanged if actual pressure is decreasing, but may be aggressivelyreduced if pressure is not decreasing with the amount of the reductionbased, at least in part, upon the deviation between actual pressure andSet Point Level. In an exemplary Reverse mode, pump rotation may bereversed (e.g., at a fluid flow rate of about 130 ml/min) until actualpressure is reduced to the appropriate Zone.

In some exemplary embodiments, the control scheme employed at aparticular time may depend on current and previous Zones of actualpressure as set forth in the following table:

Current Previous Zone Zone Mode 0 — Slope 1 0 Slope 2 1 Control 3 2Reduction (if flow rate > 0); Otherwise Reverse 4 3 Reduction (if flowrate > 0); Otherwise Reverse 3 4 Reduction (if flow rate > 0); OtherwiseReverse 2 3 or 4 Coast 1 2 Control 1 3 or 4 Slope

In some exemplary embodiments, an overpressure alarm may be delayed fora short period (e.g., 5 seconds) to allow reversal of pump 112 tocorrect an overpressure condition.

An exemplary embodiment may provide automatic and/or manual primingfunctions. For example, an exemplary automatic priming function may beinitiated by a user after installing a tubing set and connecting thetubing set to one or more fluid bags 902, 904. An exemplary automaticpriming sequence may include running pump 112 until liquid is detectedby bubble detector 132, and may include continuing to run pump 112 afterliquid is detected by bubble detector 132. For example, pump 112 maycontinue to run after liquid is detected by bubble detector 132 todeliver a predetermined volume to fill the remainder of the tubing setprovided the user has opened the irrigation valves in the downstreamtrumpet valve or surgical instrument to vent air. In some exemplaryembodiments, the predetermined volume pumped after liquid is detected bybubble detector 132 may vary depending on the type of tubing set beingutilized. For example, the fluid management system 10 may be programmedto automatically prime certain known types of tubing sets. An exemplarymanual priming function may include a user starting and stopping thepump 112 using a user interface, such as pressing and releasing a buttonon touch screen display 106. A user may employ the manual primingfunction to prime a tubing set for which the fluid management system 10is not programmed for automatic priming, to perform additional primingsubsequent to automatic priming, and/or whenever it is desired tomanually prime a tubing set, for example.

In some exemplary embodiments, detection of fluid by bubble detector 132during automatic and/or manual priming may result in initiation of fluidwarming by heating assembly 309. In some exemplary embodiments, fluidmay be warmed during priming subsequent to detection of fluid by bubbledetector 132 to reduce the amount of unwarmed fluid in the tubing set.In such embodiments, overheating of cartridge 410 (such as may occur ifheating was initiated without fluid in cartridge 410) may be avoided byutilizing the detection of liquid by bubble detector 132 as anindication of proper priming.

An exemplary embodiment may be operated in a flow control mode. A flowrate may be determined using a known flow rate per rotation of the pump112 and the rotational speed of the pump 112, for example. In some otherexemplary embodiments including other types of positive displacementpumps, the flow rate may be determined in a similar manner. In someexemplary embodiments, a flow rate sensor may be utilized to measure aflow rate. In an exemplary flow control mode, the rotational speed (orequivalent for other types of pumps) may be increased or decreased tominimize or reduce a deviation between a set point flow rate and theflow rate determined from the pump speed, flow rate sensor, etc. Anexample flow control mode may employ pressure sensors 2068, 2070 toprevent an overpressure condition. For example, the user may select amaximum allowable pressure, which may be approximately 3× the actualfluid pressure in the “open valve” configuration of the trumpet valve orsurgical instrument necessary to achieve the desired fluid flow rate andpump 112 may be operated to provide the desired flow rate, withoutexceeding the maximum allowable pressure. Thus, if fluid flow isobstructed (e.g., by shutting the irrigation valve on a trumpet valve),pump 112 will stop operating prior to reaching the maximum allowablepressure. Once the pressure is reduced (e.g., by opening the irrigationvalve on the trumpet valve), pump 112 may resume operation to deliverthe desired flow rate.

In some exemplary embodiments, fluid management unit 100 may be operatedin an infusion mode. An example infusion mode may be generally similarto the flow control mode described above. For example, an infusion modemay allow a user to input a desired flow rate, such as by using touchscreen 106. Similar to the flow control mode described above, an exampleinfusion mode may include a maximum allowable pressure. Pump 112 may bestopped or slowed if the output pressure approaches and/or reaches themaximum allowable pressure. In addition, as mentioned above, one or morebubble detectors 132 may monitor fluid being delivered to the patient.Pump 112 may be stopped if a bubble is detected by one or more bubbledetectors 132.

In some example embodiments, fluid management unit 100 may be configuredto perform a deficit monitoring function. In some example embodiments,deficit monitoring may be based at least partially upon an assumptionthat fluid may be one of four places: in the fluid supply containers(e.g., fluid bags 902, 904), in the tubing set, in the patient, and/orin the fluid collection containers (e.g., canisters 906, 908, 910, 912).Any fluid that is not in the fluid supply containers, the tubing set, orin the fluid collection containers is assumed to be in the patient.Thus, some example embodiments may utilize total system weights (e.g.,the weight of the fluid supply containers plus the fluid collectioncontainers) to calculate the amount of fluid that may be in the patient(e.g., the deficit). For example, after the tubing has been primed, an“initial total system reference weight” may be calculated from theinitial weight of the fluid supply containers (e.g., fluid bags 902,904), as determined by load cells 142, 144 and from the initial weightof the fluid collection containers (e.g., canisters 906, 908, 910, 912),as determined by load cells 206A, 206B, 206C, 206D. The “initial totalsystem reference weight” may be determined (e.g., at the beginning of aprocedure when the “run” button is pressed) by summing the initialweight of the fluid supply containers and the initial weight of thefluid collection containers. As the fluid management unit 100 operates,the weight of the fluid supply containers and the weight of the fluidcollection containers are monitored by controller at periodic timeintervals. At each time interval, a deficit may be calculated bysubtracting the combined weights of the fluid supply containers and thefluid collection canisters, as measured at that time, from the initialtotal system reference weight. In some exemplary embodiments, theperiodic time intervals may be sufficiently short (e.g., a fraction of asecond) such that the deficit is effectively continuously monitored(e.g., a plurality of times per second). The calculated deficit is anindication of fluid that may be within the patient at the time thedeficit is calculated. The calculated deficit at a time interval may bedisplayed on displays 106, 106A when calculated by the controller forobservation by a user of fluid management unit 100.

Some exemplary fluid management units may be configured to automaticallydetect fluid supply container and/or fluid collection containerreplacements. For example, replacement of a fluid supply container(e.g., an empty or near empty fluid supply container with a full fluidsupply container) may be detected by observation of a substantialincrease in the sensed weight of the fluid supply containers. Similarly,replacement of a fluid collection container (e.g., a full or nearly fullfluid collection container with an empty fluid collection container) maybe detected by observation of a substantial decrease in the sensedweight of the fluid collection containers. Bumping or shaking of fluidmanagement unit 100 to may cause momentary weight errors, so someexample fluid management units 100 may be configured to allow a periodof time for any transient conditions to dissipate. Thus, transientweight errors may be automatically corrected when the transient ends.

Some example fluid management units 100 may automatically account forfluid supply container replacements by noting the change in fluid supplycontainer weight when the replacement occurs. The change in weight maythen be added to the system total reference weight to provide an updatedtotal system reference weight for use in subsequent deficitdeterminations. Similarly, some example fluid management units 100 mayautomatically account for fluid collection container replacements bynoting the change in fluid collection container weight when thereplacement occurs. The change in weight may then be subtracted from thesystem total reference weight to provide an updated total systemreference weight for use in subsequent deficit determinations. Someexample systems may automatically account for a plurality of fluidsupply container replacement and/or fluid collection containerreplacement in this manner on an ongoing basis by updating the referencetotal system weight each time a replacement occurs.

FIG. 41 illustrates an example method 4100 of operating a surgical fluidmanagement system. Operation 4102 may include delivering fluid from afluid supply container to a surgical site via a tubing set. Operation4104 may include sensing a system fluid pressure in the tubing setbetween the fluid supply container and the surgical site. Operation 4106may include sensing a surgical site fluid pressure using a remotepressure sensor disposed approximate the surgical site. Operation 4108may include controlling a pressure of the fluid delivered to thesurgical site based at least in part upon at least one of the sensedsystem fluid pressure and the sensed surgical site fluid pressure.

FIG. 42 illustrates an example method 4200 of operating a surgical fluidmanagement system. Operation 4202 may include delivering fluid to asurgical site using a pump. Operation 4204 may include controllingoperation of the pump based at least in part upon a pressure trend, thepressure trend including a current measured pressure as compared to aset point pressure and a previous measured pressure as compared to theset point pressure.

FIG. 43 illustrates an example method 4300 of operating a surgical fluidmanagement system. Operation 4302 may include delivering fluid to asurgical site using a pump. Operation 4304 may include controllingoperation of the pump including selecting one of a plurality of pressurecontrol modes based at least in part upon measured conditions, andadjusting operation of the pump using the selected control mode.

FIG. 44 illustrates an example method 4400 of operating a surgical fluidmanagement system. Operation 4402 may include delivering fluid to asurgical site via a heater assembly, the heater assembly including atleast a first heater and a second heater, the fluid flowing past thefirst heater and then flowing past the second heater. Operation 4404 mayinclude supplying power to the first heater based at least in part uponan estimated power requirement, the estimated power requirement beingsubstantially proportional to a flow rate of the fluid and a totaldesired temperature change of the fluid. Operation 4406 may includesupplying power to the second heater, including, if a current outlettemperature is less than a set point outlet temperature by greater thana predetermined threshold, supplying power to the second heater basedupon a first heater control algorithm, and if the current outlettemperature is less than the set point outlet temperature by less than apredetermined threshold, supplying power to the second heater based upona second heater control algorithm.

FIG. 45 illustrates an example method 4500 of monitoring a fluid deficitin a surgical fluid management system. Operation 4502 may includemeasuring an initial weight held by a fluid supply container support,the fluid supply container support supporting a first fluid supplycontainer. Operation 4504 may include measuring an initial weight heldby a fluid collection container support, the fluid collection containersupport supporting a first fluid collection container. Operation 4506may include calculating an initial reference total weight, the initialreference total weight including a sum of the initial fluid supplycontainer support weight and the initial fluid collection containersupport weight. Operation 4508 may include supplying fluid from thefirst fluid supply container to a surgical site. Operation 4510 mayinclude collecting at least some of the fluid from the surgical siteinto the first fluid collection container. Operation 4512 may includemeasuring a first current weight held by the fluid supply containersupport. Operation 4514 may include measuring a first current weightheld by the fluid collection container support. Operation 4516 mayinclude calculating a first current total weight, the first currenttotal weight including a sum of the first current weight held by thefluid supply container support and the first current weight held by thefluid collection container support. Operation 4518 may includecalculating a first fluid deficit by subtracting the first current totalweight from the initial reference total weight.

FIG. 46 illustrates an example method 4600 of monitoring a fluid deficitin a surgical fluid management system. Operation 4602 may includemeasuring an initial weight held by a fluid supply container support,the fluid supply container support supporting at least one fluid supplycontainer. Operation 4604 may include measuring an initial weight heldby a fluid collection container support, the fluid collection containersupport supporting at least one fluid collection container. Operation4606 may include calculating an initial reference total weight, theinitial reference total weight including a sum of the initial fluidsupply container support weight and the initial fluid collectioncontainer support weight. Operation 4608 may include supplying fluidfrom the at least one fluid supply container to a surgical site.Operation 4610 may include collecting at least some of the fluid fromthe surgical site into the at least one fluid collection container.Operation 4612 may include monitoring a current weight held by the fluidsupply container support. Operation 4614 may include monitoring acurrent weight held by the fluid collection container support. Operation4616 may include calculating a current total weight, the current totalweight including a sum of the current weight held by the fluid supplycontainer support and the current weight held by the fluid collectioncontainer support. Operation 4618 may include calculating a currentfluid deficit by subtracting the current total weight from the initialreference total weight.

FIG. 47 illustrates an example method 4700 of operating a surgical fluidmanagement system. Operation 4702 may include calculating an initialreference total weight, the initial reference total weight including asum of an initial weight of a fluid supply container and an initialweight of a fluid collection container. Operation 4704 may includesupplying fluid from the fluid supply container to a surgical site.Operation 4706 may include collecting at least some of the fluid fromthe surgical site into the fluid collection container. Operation 4708may include calculating a current total weight, the current total weightincluding a sum of a current weight of the fluid supply container and acurrent weight of the fluid collection container. Operation 4710 mayinclude calculating a deficit by subtracting the current total weightfrom the initial reference total weight.

FIG. 48 illustrates an example method 4800 of operating amulti-functional fluid management system. Operation 4802 may includereceiving, via a user interface, at least one of a surgical disciplineselection and a surgical procedure selection. Operation 4804 may includesetting at least one default operating limit based at least in part uponthe at least one of the surgical discipline selection and the surgicalprocedure selection.

FIG. 49 illustrates an example method 4900 of operating a surgical fluidmanagement system. Operation 4902 may include receiving, via a userinterface, identification of information to be gathered by a surgicalfluid management system during a surgical procedure. Operation 4904 mayinclude electronically storing the information during the surgicalprocedure. Operation 4906 may include receiving, via the user interface,an instruction pertaining to at least one of printing, storing, andelectronically transmitting the information.

FIG. 50 illustrates an example method 5000A of operating amulti-functional surgical fluid management system. Operation 5002A mayinclude receiving, via a user interface, identification of at least oneof a surgical discipline and a surgical procedure. Operation 5004A mayinclude setting default operating parameters based upon the at least oneof the surgical discipline and the surgical procedure. Operation 5006Amay include receiving, via a user interface, input to adjust theoperating parameters.

FIG. 51 illustrates an example method 5100 of operating a surgical fluidmanagement system. Operation 5102 may include receiving, via a userinterface, preferred operating settings associated with at least one ofa surgical discipline and a surgical procedure, the preferred operatingsettings also being associated with an identity of at least one of asurgeon and an operator. Operation 5104 may include setting operatingparameters at the preferred operating settings upon receiving an input,via a user interface, associated with at least one of the surgeon andthe operator and at least one of the surgical discipline and thesurgical procedure.

FIG. 52 illustrates an example method 5200 of controlling a surgicalfluid management device. Operation 5202 may include receiving, via auser input, identification of information which must be entered prior tooperation of a surgical fluid management device. Operation 5204 mayinclude requesting entry of the information. Operation 5206 may includeif the information has not been entered, precluding operation of the ofthe surgical fluid management device. Operation 5208 may include if theinformation has been entered, allowing operation of the surgical fluidmanagement device.

As has been described above, the present invention is directed to afluid management system 10 for managing fluids used in connection with awide variety of “medical procedures” that may be performed in connectionwith humans and animals. As should be apparent from the inventiondisclosure provided above, the term “medical procedure” as used in thepresent application refers to procedures, including, but not limited to:surgical procedures, irrigation procedures, and infusion procedures,said procedures performed on humans or animals. It should be understoodthat a medical procedure may be comprised of multiple elements, whereineach element is an individual medical procedure. In other words, aplurality of individual medical procedures may be carried out insuccession to complete a comprehensive medical procedure. Thus, “medicalprocedure” may refer to an individual medical procedure or acomprehensive medical procedure comprised of a plurality of individualmedical procedures.

The medical procedures may be associated with such medical disciplines,including but not limited to: gynecology, obstetrics, urology,orthopedics, general surgery and trauma. Examples of medical procedures,include but are not limited to, hysteroscopy, cystoscopy, ureteroscopy,laparascopy, arthroscopy, and infusion. These medical procedures areidentified in general or specific terms.

The medical procedures carried out with use of fluid management system10 disclosed herein may involve one or more of the following fluiddelivery functions, including but not limited to: fluid irrigation,distention of a body cavity, and fluid infusion into a patient. Fluidmanagement system 10 of the present invention may also provideadditional functions with respect to the medical procedures, including,but not limited to: fluid deficit monitoring associated with deliveryand return of fluid to/from a site (wherein, the site is a surgical siteor a patient), fluid warming, fluid pulsation, and circulation of fluid(e.g., into and out of a body cavity).

Depending upon the selected medical procedure, fluid management system10 operates in either a pressure control mode (wherein control system 8controls pump 112 to deliver fluid to the site at approximately a targetpressure), or in a flow control mode (wherein control system 8 controlspump 112 to deliver fluid to the site at approximately a target flowrate).

In order to safely and effectively deliver fluid for carrying out themedical procedure, several “default” operating parameters areestablished in accordance with the medical procedure selected by theuser. These default operating parameters include, but are not limitedto, a target pressure and a target flow rate. A range of acceptablepressures and flow rates are respectively defined by minimum and maximumpressures and minimum and maximum flow rates. By maintaining thepressure within the acceptable pressure range and maintaining the flowrate within the acceptable flow rate range, fluid management system 10of the present invention safely and effectively delivers fluid to thesite in connection with the selected medical procedure.

Described below are additional features of the present invention.Certain aspects of these features have been described in the preceedingsections of the specification.

Heating Suspension

In accordance with one embodiment of the present invention, heaterassembly 309 is disabled when pump 112 is inactive (i.e., not rotating),unless fluid management system 10 is in an “idle” state. Thisdisablement of heater assembly 309 prevents any dangerous conditionsthat could arise from heating stagnant fluid in cartridge 410. Controlsystem 8 is programmed to deactivate pump 112 when a threshold fluidpressure (P_(threshold)) is detected by control system 8 (e.g., usingpressure sensors 2068, 2070). The threshold fluid pressure(P_(threshold)) is typically achieved when a user closes an inflow oroutflow valve on a surgical instrument, or tubing downstream ofcartridge 410 is intentionally or unintentionally occluded.

However, it is recognized that if tubing located upstream of cartridge410 is occluded or the fluid supply source (i.e., fluid supplycontainer(s); fluid bags 902, 904) have become depleted, then pump 112continues to be activated due to the fact that the threshold fluidpressure (P_(threshold)) cannot be achieved. As a result, heaterassembly 309 continues to be enabled (even though the fluid in cartridge410 is stagnant). This situation may result in undesirable conditions,such as overheating of the fluid in cartridge 410.

According to an aspect of the present invention, control system 8 isprogrammed to monitor the weight of the fluid supply source when pump112 is in an activate state, and thereby determine whether or not fluidis “flowing.” As discussed above, one or more load cells 142, 144, mayoutput electrical signals associated with the weight of the fluid supplycontainers suspended from the fluid bag hangers. Control system 8determines whether the weight of the fluid supply source is decreasing.If the weight of the fluid supply source is not decreasing, then controlsystem 8 determines that tubing upstream of cartridge 410 is occluded,or that the fluid supply source has become depleted, and thus disablesheater assembly 309 to prevent any further heating of the fluid.

If a user selects a medical procedure that allows fluid heating and theuser has enabled the fluid heating function (e.g., by selecting heaterbutton 4064 as shown in FIG. 35), then heater assembly 309 will continueto be enabled if (a) pump 112 is activated; (b) bubble detector 132 issensing the presence of fluid; and (c) the weight of the fluid supplysource is decreasing. If any one of the conditions (a), (b) or (c) isnot present, then heater assembly 309 will be disabled to stop furtherheating of the fluid in cartridge 410.

In accordance with an alternative embodiment, control system 8 does notmonitor the weight of the fluid supply source, but instead, receives asignal from a flow sensor located along a fluid path upstream ofcartridge 410 indicative of whether fluid is flowing along the fluidpath.

Manual Lost Fluid Estimator

In accordance with certain medical procedures (such as operativehysteroscopy), fluid absorption by a patient must be carefully monitoredto guard against excess fluid absorption, which may result incomplications. The amount of fluid that can be safely absorbed by thepatient is dependent upon a number of factors, including the type offluid being used.

In some fluid management systems, the fluid deficit is monitored bymeasuring the amount of fluid delivered to a site and the amount offluid returned from the site (e.g., via suction or gravity). Such fluidmanagement systems may provide an alarm when the fluid deficit isapproaching an unsafe level, and prevent any further fluid delivery tothe site when the fluid deficit has reached an unsafe limit. However,such fluid management systems are not able to measure the amount offluid that is “lost” including, but not limited to, fluid that hasspilled onto the floor and/or has been absorbed by surgical drapes,gowns, and/or blankets. As a result, such “lost” fluid is deemed by thefluid management system to have been absorbed by the patient, andthereby results in an artificially high fluid deficit. Consequently, theuser may experience corresponding false fluid deficit alarms, procedureinterruptions, and/or premature terminations of procedures.

According to an aspect of the present invention, control system 8 isprogrammed to present the user with a data entry screen (via touchscreen 106) that allows the user to manually enter a value that is anestimate of the amount of fluid “lost” during a medical procedure. Thisvalue may be entered in units of volume or weight.

Control system 8 incorporates the “lost” fluid estimate into the fluiddeficit calculations (such as those described in detail above), thusproviding the user with a fluid deficit having greater accuracy. Forexample, the “lost” fluid estimate may be incorporated into the fluiddeficit calculations by subtracting the weight of the estimated “lost”fluid from the initial total system weight, or by adding the weight ofthe estimated “lost” fluid to the current total system weight.

To minimize the risk associated with “lost” fluid estimates and toensure accountability for users making and manually entering the “lost”fluid estimates, control system 8 may also be programmed to provide oneor more of the following features:

-   -   1. Visually and/or audibly providing a warning (via touch screen        106 and/or speaker 2052) to the user against overestimating the        “lost” fluid due to inaccurate fluid deficit monitoring and        corresponding adverse consequences that could result from        overestimations;    -   2. Visually and/or audibly providing a warning (via touch screen        106 and/or speaker 2052) to the user against entering “lost”        fluid estimates considered nominal in nature (e.g., less than        100 ml);    -   3. Providing a “lost” fluid estimate on a printed procedure        summary that may be printed by printer 111 at the completion of        a medical procedure to provide a printed record of the medical        procedure. Printer control box 4082 may provide a user with a        selection for printing the “lost” fluid estimate at the end of a        medical procedure (see FIG. 37); and    -   4. Programming control system 8 to prohibit the “lost” fluid        estimate from being incorporated into fluid deficit calculations        during the medical procedure in order to eliminate the        possibility of a user manipulating or effectively raising the        fluid deficit alarm limit by overestimating the amount of “lost”        fluid. In this case, the only purpose for manual entry of the        “lost” fluid estimate would be to have such estimate printed in        the procedure summary for a more accurate record of the fluid        deficit occurring during the medical procedure.

Default Maximum Fluid Deficit by Fluid Type

As discussed above, the amount of fluid that can be safely absorbed by apatient is dependent upon a several factors, including the type of fluidbeing used. However, some fluid management systems default to a fluiddeficit alarm limit that is independent of the type of fluid being used,and thus allows a user to adjust the fluid deficit alarm limit within arange inclusive of all permissible levels of fluid absorption for alltypes of fluids that could be used during a medical procedure. As aresult, a user may program the fluid management system with a fluiddeficit alarm limit set to a high limit (e.g., 2500 ml) when the fluidmanagement system is being used to supply a fluid that requires a lowerfluid deficit alarm limit (e.g., 1500 ml).

In accordance with an aspect of the present invention, where deficitmonitoring is enabled, control system 8 is programmed to prompt a userto enter or select a “type” of fluid to be used in connection with themedical procedure, via touch screen 106. Control system 8 defaults to anappropriate/safe fluid deficit alarm limit for the entered or selectedfluid “type” and allows the user to adjust such fluid deficit alarmlimit within a range deemed safe for that particular “type” of fluid.The “type” of fluid indicated by the user, the fluid deficit alarm limitset by the user, and the total fluid deficit may be provided on aprinted procedure summary at the conclusion of the medical procedure.

Alternatively, control system 8 may default to a fluid deficit alarmlimit deemed safe for all possible fluids and only prompt the user toenter or select the fluid “type” if the user desires to increase thefluid deficit alarm limit above the initial default fluid deficit alarmlimit or other low fluid deficit alarm limit.

Deficit Monitoring by Type of Fluid Used and Purge Button

During certain medical procedures, including operative hysteroscopyhaving both hysteroscopic and laparoscopic elements, it may be necessaryto change the tubing set and the type of fluid being used during theprocedure to accomplish the respective distention and/or irrigationfunctions. For example, in the hysteroscopic element, an endoscopictubing set and saline fluid may be used. In the laparoscopic element, alaparoscopic tubing set and a non-conductive fluid (such as glycine) maybe used in order to perform electrocautery. It may also be necessary toreturn to the hysteroscopic element (i.e., endoscopic tubing and saline)to complete the procedure.

Fluid management system 10 is operable in both pressure and flow controlmodes, and includes tubing sets that facilitate the transition betweento two or more elements of a procedure (e.g. between hysteroscopic andlaparoscopic elements). These tubing sets include a proximal portionthat includes cartridge 410, and a distal portion downstream ofcartridge 410 that terminates in a connector, such as a luer lockconnector (e.g., for hysteroscopic use) or a surgical instrument, suchas a trumpet valve (e.g., for laparoscopic use). For example, see FIGS.9 and 24. It is contemplated that other types of connectors andinstruments may be used in connection with the present invention.

In one embodiment of the present invention, the distal portion isadapted to be interchangeable, i.e., a distal portion terminating in afirst type of connector (e.g., a luer lock connector) can beinterchanged with a distal portion terminating a surgical instrument(e.g., a trumpet valve) or a second type of connector. This allows aluer lock connector to be interchanged with a trumpet valve, therebyfacilitating a transition between different medical procedures (e.g.,laparoscopic and hysteroscopic procedures). Interchangeable distalportions are discussed in detail below.

If the fluid used during a second element of a procedure is differentfrom the fluid used during a first element of the procedure, then a usermust ensure that the fluid used in the first element of the procedure iscompletely purged from fluid management system 10 prior to commencingthe second element of the procedure. This requires the user to manuallyestimate the amount of fluid that must be pumped to completely purge thefluid used in the first element of a procedure. Moreover, the user mustmanually track the fluid deficit associated with the first element ofthe procedure and the fluid deficits associated with any subsequentelements of the procedure in order to have an accurate total fluiddeficit.

In accordance with another aspect of the present invention, controlsystem 8 is programmed to present the user with a prompt or data entryscreen (via touch screen 106) that allows the user to indicate atransition from a first element of a procedure to a second element ofthe procedure (e.g., from a hysteroscopic element to a laparoscopicelement). Upon such indication, control system 8 uses touch screen 106to prompt the user to select the procedure associated with the secondelement; instruct the user to change the distal portion of tubing; andquery the user whether a different fluid will be used for the secondelement of the procedure and, if so, prompts the user to enter or selectthe “new” fluid via touch screen 106. If the user indicates that adifferent fluid will be used for the second element of the procedure,control system 8 is programmed to display a “purge” button that, whenpressed, causes control system 8 to activate pump 112 in order to pump asufficient volume of the “new” fluid to thereby completely purge the“old” fluid from the proximal portion of the tubing set beforeconnecting the new distal portion.

Control system 8 is further programmed to incorporate theabove-described “purge” function into the fluid deficit monitoringcalculations (described above) in order to avoid artificially high fluiddeficit and corresponding false alarms, procedure interruptions, and/orearly procedure terminations. For example, the volume of “purged” fluidmay be incorporated into the fluid deficit calculations by subtractingthe weight of the “purged” fluid from the initial total system weight,or by adding the weight of the “purged” fluid to the current totalsystem weight.

Control system 8 is also programmed to present the user with the “purge”button if the user indicates to control system 8 that a fluid change isgoing to be made during a single element of the procedure (e.g., duringa hysteroscopic element). In this situation the distal portion remainsunchanged. As a result of selecting the “purge” button, control system 8performs the fluid “purge” and adjusts the fluid deficit monitoringlevels accordingly.

Control system 8 is further programmed to automatically track anddisplay (a) the fluid deficit associated with the “old” fluid usedduring the first element of the procedure; (b) the fluid deficitassociated with the “new” fluid used during the second element of theprocedure; and (c) the total fluid deficit for the entire procedure(i.e., all elements of the procedure). Furthermore, if there is a third(or subsequent) element(s) of the procedure (e.g., hysteroscopic elementchanging to laparoscopic element changing back to hysteroscopicelement), control system 8 is programmed to track and display the fluiddeficits based on the fluid used during that element.

Change Canister Prompt

Fluid management unit 100 is capable of sensing a significant weightchange indicative of the replacement of a fluid collection container. Auser may be presented with a “change canister” button displayed on touchscreen 106 to eliminate potential errors that can be caused by movementor vibration of fluid management unit 100 (e.g., shifting of fluidinside canisters 906, 908, 910, 912). However, if the user fails topress the “change canister” button, the volume of the fluid associatedwith the full fluid supply container that was removed is no longeraccounted for and, therefore, deemed by control system 8 to have beenabsorbed by the patient. This situation can result in an artificiallyhigh fluid deficit calculation and display, as well as accompanyingfalse alarms, procedure interruptions, or early procedure terminations.

According to an aspect of the present invention, control system 8 isprogrammed to sense a large decrease in weight on load cell base 204indicative of the removal of a full or substantially full fluid supplycontainer, without the user having pressed the “canister change” button.Furthermore, control system 8 is programmed to store the weightdetermined prior to the significant weight change, and displays a queryon touch screen 106 to request the user to confirm that a fluid supplycontainer has been removed (e.g., “Did you just remove a canister? Ifso, please press canister change button now”). As described above, thetotal weight supported by load cells 206A, 206B, 206C, 206D is aboutequal to the sum of the weight of suction canister hanger 202, the emptyweights of canisters 906, 908, 910, 912, and the weight of any contentsof canisters 906, 908, 910, 912.

Bolus Button

During certain medical procedures (e.g., ureteroscopy), a user may needa bolus of higher pressure fluid to carry out a particular mechanicalfunction (such as move kidney stones, separate tissue, expandpassageways, etc.). The bolus can be achieved via a syringe or bulb thatis manually operated by the user. This approach may result in unsafefluid pressure levels or volumes, and often requires a separate tubingset which can be inefficient and costly.

In accordance with an aspect of the present invention, when a userselects a medical procedure where a “bolus” of fluid might be necessary(e.g., ureteroscopy), control system 8 is programmed to display (viatouch screen 106) a “bolus” button that can be selected by the user atany time during the procedure. Upon selection of the “bolus” button,control system 8 is programmed to provide a “bolus” of fluid. The usermay set parameters associated with the “bolus” including, but notlimited to, a desired fluid pressure level and a desired duration (ineither time or fluid volume). It is also contemplated that controlsystem 8 may be programmed to display numerous “bolus” buttons, whereineach button is associated with a specific pressure and durationcombination. This feature enables the user to more efficiently employthe correct “bolus” without having to “reprogram” a single “bolus”button for different pressure and duration combinations.

Intra-Procedure Multi-Functionality

In the medical discipline of gynecology, the associated procedures mayinvolve both hysteroscopic and laparoscopic elements of a procedure.Typically, these procedures will commence with diagnostic or operativehysteroscopy and progress to gynecologic and/or abdominal laparoscopy.Fluid management systems that require the use of multiple devices and/ormultiple tubing sets to complete such types of multi-element proceduresdecrease efficiency, increases the costs associated with suchprocedures, and might potentially adversely affect patient safety.

In hysteroscopy, irrigation fluid is circulated into and out of theuterine cavity at a pressure deemed optimal to maintain properdistention and to achieve good visualization by washing out blood anddebris resulting from the procedure. Due to the dangers associated withintravasation, the fluid deficit (i.e., the difference in volume betweenthe amount of fluid delivered to a site and the amount of fluid returnedfrom the site), must be closely monitored by the fluid managementsystem. Also, due to procedural requirements and/or the adverse outcomesassociated with intraoperative hypothermia, warming of the irrigationfluid to approximately body temperature may be necessary or desired.

In laparoscopy, the irrigation fluid is delivered to the site at a flowrate deemed appropriate to clear the site of blood and debris and tomaintain good visualization. Again, due to procedural purposes and/orthe adverse outcomes associated with intraoperative hypothermia, warmingof the irrigation fluid to approximately body temperature may be desiredor necessary.

Due to functional limitations of certain existing fluid managementsystems, procedures that include multiple elements (e.g., hysteroscopicand laparoscopic elements) may require the use of multiple fluidmanagement systems during such procedures. These functional limitations,include, but are not limited to: single operating mode (i.e., operablein a pressure control mode or a fluid control mode, but not both modes);lack of tubing sets that can be configured for hysteroscopic andlaparoscopic use (i.e., requiring the use of separate tubing sets foreach element of a procedure); lack of automated deficit monitoringcapabilities; lack of user-selectable on-demand fluid warmingcapabilities; and lack of trumpet valves with suction/irrigation andelectrocautery capability.

According to an aspect of the present invention there is provided a“multi-functional” fluid management system 10 that includes a fluidmanagement unit 100 that operates in fluid pressure control mode or flowcontrol mode depending upon a selected medical procedure, monitors fluiddeficits, provides on-demand fluid warming; and provides a tubing setthat is configurable for various different medical procedures, such ashysteroscopy and laparoscopy (suction/irrigation alone or in combinationwith electrocautery).

FIG. 53A illustrates a trumpet valve tubing set 3010 useable inconnection with a first medical procedure (e.g., a laparoscopicprocedure), while FIG. 53B illustrates a luer lock connector (singlelumen) tubing set 3010′ useable in connection with a second medicalprocedure (e.g., a hysteroscopic procedure). Each tubing set 3010, 3010′is comprised of a cartridge or proximal portion 3015 and a distalportion 3017, 3017′. The proximal portion includes dual spikes 3014 withclamps 3016, 3018, a “Y” connector 3020, a first section 3013A of tubingconnecting “Y” connector 3020 and a cartridge 410 (fluid inflow),cartridge 410, and a second section 3013C of tubing (with a clamp 3015B)that connects cartridge 410 and a connector 3015A (fluid outflow).

Distal portions 3017, 3017′ are adapted for use with a particularmedical procedure. In the illustrated embodiment, distal portion 3017provides a trumpet valve, while distal portion 3017′ provides a singlelumen terminating in a luer lock connection or other connection to asurgical instrument. It is contemplated that the distal portion may beadapted for use with devices other than those illustrated herein.

Distal portion 3017 includes a tubing section 3013D (irrigation line)and a connector 3017A for connection to proximal portion 3015 of tubingset 3010. In the illustrated embodiment, tubing section 3013D terminatesat the distal end in a trumpet valve 3022 and a conjoined suction tubingor line 3027 that terminates in a standard suction connector 3026.

Distal portion 3017′ includes a tubing section 3013E (irrigation line)and a connector 3017A with an optional clamp 3017B for connection toproximal portion 3015 of tubing set 3010′. In the illustratedembodiment, tubing section 3013E terminates at the distal end in a luerlock 3019 with a clamp 3019A

For example, fluid management system 10 may be configured for ahysteroscopy procedure by selecting the hysteroscopy procedure from amedical procedure menu (e.g., see FIG. 32), which automatically putsfluid management system 10 in a pressure control mode. A user installsproximal portion 3015 of tubing set 3010′ (FIG. 53B) that includes dualbag spikes 3014 and “y” connector 3020, a cartridge 410 that is inserted410 into slot 310 (see FIG. 2), and a segment 3013C of tubing extendingfrom cartridge 410 to a male or female connector 3015A for enablingcoupling to distal portion 3017′ of tubing set 3010′ outside of fluidmanagement unit 100. Distal portion 3017′ includes mating connector3017A and segment 3013E of tubing for delivering fluid from fluidmanagement unit 100 to the site. Segment 3013E of tubing terminates inluer lock connector 3019 for coupling to a hysteroscope or otherinstrument.

Control system 8 facilitates transitions between two different elementsof a procedure. For example, when the hysteroscopic element of theprocedure is complete, or it becomes necessary to interrupt thehysteroscopic element of the procedure to perform a laparoscopicelement, the user indicates to control system 8, via touch screen 106, achange in the medical procedure to laparoscopy. As a result, controlsystem 8 automatically transitions the fluid management unit 100 to aflow control mode.

The user disconnects distal portion 3017′ of the tubing used forhysteroscopy from proximal portion 3015, and connects distal portion3017 (FIG. 53A) to proximal portion 3015. Proximal portion 3015 includesmating connector 3015A that couples to connector 3017A of distal portion3017. Distal portion 3017 includes segment 3013D of tubing thatterminates in trumpet valve 3022, for delivering fluid from fluidmanagement system 10 to the site. Trumpet valve 3022 has a standardsuction/irrigation probe or a combination probe that includessuction/irrigation and electrocautery. When the distal portionsubstitution has been completed by the user, the user will indicate tocontrol system 8 (via touch screen 106) that fluid management system 100is properly configured to start the laparoscopic element of theprocedure. If a different fluid is being used, then the “purge” functiondescribed above may be implemented.

Although fluid deficit is less of a concern during laparoscopy, controlsystem 8 is programmed to prompt the user (via touch screen 8) toindicate whether the user wants to continue fluid deficit monitoring. Ifthe user elects to continue the deficit monitoring, control system 8will regard the laparoscopy element as a continuation of the sameprocedure (i.e., the originally selected procedure) for purposes of thedeficit monitoring function. If the user elects to discontinue thedeficit monitoring, control system 8 will regard the laparoscopy elementas a “new” procedure. Accordingly, the deficit monitoring function ofcontrol system 8 is adapted to facilitate changes between elements of aprocedure.

When the laparoscopic element of the procedure is complete, or when itbecomes necessary to interrupt the laparoscopic element to perform anadditional hysteroscopic element, the user indicates to control system8, via touch screen 106, a change in the procedure to return back tohysteroscopy. As a result, control system 8 automatically transitionsthe fluid management unit 100 back to a pressure control mode. Fluidmanagement unit 100 indicates, via touch screen 106, that the fluiddeficit monitoring calculations from the previous hysteroscopic elementof the procedure will be restored and comprise the basis for continuingthe fluid deficit monitoring calculations. The user changes the distalportion of tubing from the laparoscopic tubing (FIG. 53A) to thehysteroscopic tubing (FIG. 53B), and then indicates to control system 8(via touch screen 106), that fluid management system 100 is properlyconfigured to return to the hysteroscopic element of the procedure.

It should be appreciated that the following features of fluid managementsystem 10 enable performance of the functions described above: operatesin a pressure control mode or a flow control mode depending on theselected procedure; tubing sets are configurable for differentprocedures (e.g., hysteroscopic and laparoscopic procedures);microprocessor-based fluid deficit monitoring (for storing, recallingand computing fluid deficit calculations); selectable on-demand fluidwarming; and combination suction/irrigation electrocautery trumpet valveprobes.

Fluid management system 10 as described above has several advantages,including, but not limited to:

-   -   a. only one fluid management system is needed to perform a        procedure involving multiple elements (e.g. hysteroscopic and        laparoscopic elements), thereby saving time since only one fluid        device has to be set up, reducing costs since only one device        has to be acquired and maintained, and minimizing space        requirements in the operating room (OR);    -   b. only one tubing set is needed, with appropriate accessories,        thereby reducing costs over separate tubing sets needed for        hysteroscopic and laparoscopic elements;    -   c. the ability of fluid management system 10 to function for        multiple elements (e.g., both hysteroscopy and laparoscopy        elements) increases the efficiency of the procedure;    -   d. the ability of fluid management system 10 to store, retrieve,        and build upon fluid deficit calculations from a first element        (e.g., a hysteroscopic element) performed earlier in a procedure        increases patient safety by reducing possible recording errors;    -   e. the “selectable” on-demand fluid warming feature of fluid        management system 10 enables the use of fluid management system        10 in a variety of situations, i.e., when there are procedural        requirements for fluid warming (such as the warm fluid        indication in certain hysteroscopic sterilization procedures),        when there are concerns with intraoperative hypothermia that        require on-demand fluid warming, and when there are procedural        requirements or other clinical issues that require        room-temperature or cool irrigation fluid; and    -   f. the trumpet valve of fluid management system 10 can receive a        standard suction/irrigation probe or a combination        suction/irrigation and electrocautery probe, thereby saving time        and money, and eliminating the need for two separate ports into        an insufflated surgical site.    -   g. the purge function when transitioning from a first fluid to a        second fluid.

According to another embodiment of the present invention, fluidmanagement system 10 includes an automatic tubing detection feature andallows control system 8 to automatically detect changes in tubing setsin use with fluid management system 10. In this regard, control system 8is programmed to automatically recognize a change between a distalportion 3017′ of tubing set 3010′ (e.g., used for hysteroscopy) and adistal portion 3017 of tubing set 3010 (e.g., used for laparoscopy), andautomatically respond to such detected change by making a correspondingchange to system operation, e.g., changing between pressure mode controland flow control mode, and adjusting alarm limits. The automaticrecognition contemplated herein may be accomplished using detectiontechnology well know in the art, including but not limited to RFIDtagging, or a variety of other electrical (wired and wirelesscommunication devices), mechanical, optical, or pneumatic means. Anillustrated embodiment of the present invention will be described withreference to a fluid management system 10 that includes radio frequencyidentification device (RFID) tagging as an electrical communicationdevice.

As will be described in detail below, a readable memory such as an RFIDis integral with the distal portion of the tube set. The RFID includes amemory that stores data identifying characteristics of the distalportion of the tube set. An interface unit reads the data in the RFIDmemory. Based on this data, the control system 8 then regulatesoperation of fluid management system 10 according to a pressure controlmode or a flow control mode in accordance with the type of distalportion that has been detected using the RFID.

Control system 8 also controls pump 112 such that fluid, when required,is delivered at a pressure level or flow rate according to the data readout from the RFID memory. This data is also used by the control system 8to regulate priming of pump 112 so that when fluid management system 10is initially setup, a head of irrigation fluid can be pumped close tothe end of the hand piece tool from which the fluid is to be discharged.

Referring now to FIGS. 53A and 53B, respective distal portion 3017,3017′ of tube sets 3010, 3010′ include an RFID 3142. RFID 3142 includesa memory in which data is stored that identifies characteristics ofdistal portion 3017, 3017′ (e.g., which type(s) of medical procedure(s)use the distal portion, whether the distal portion is used in connectionwith a pressure control mode or a flow control mode, and associatedpressure level or flow rate). RFID 3142 also includes the followingcomponents that facilitate the reading of data to and the writing ofdata from the memory: a coil, a signal modulator/demodulator; aprocessor; and a rechargeable power supply.

With reference to FIG. 54, control system 8 is modified to include anRFID interface unit 3122 for communicating with RFID 3142. In thisregard, interface unit 3122 reads data from and writes data to RFID3142. Interface unit 3122 includes an antenna that is positioned suchthat when the distal portion 3017 or 3017′ is positioned for connectionwith proximal portion 3015, the antenna and the coil integral with RFID3142 are close enough to facilitate inductive signal transfertherebetween. Interface unit 3122 also includes a modulator/demodulatorfor encoding the signals for forwarding data to RFID 3142 and decodingreceived signals received from RFID 3142. Once a distal portion 3017 or3017′ is connected with proximal portion 3015, data is read out of theRFID memory. It should be appreciated that interface unit 3122 mayalternatively be located at cartridge 410 and communicate with processor2050 via wireless or wired communications.

A manual process (as described above) may be used as the primary meansfor indicating to fluid management unit 100 that a change in the type ofprocedure is occurring, and the automatic tubing detection featureserving as a secondary redundant safety check. For example, if the usermanually indicates, via touch screen 106, that a change to a laparoscopyprocedure was going to occur, but mistakenly couples a distal portion oftubing intended for a hysteroscopy procedure, control system 8 isprogrammed to identify this error, and notify the user of the mistakevia the touch screen 106 and preclude operation of fluid managementsystem 10 until the correct distal portion of tubing is attached.

It should be further noted that a configurable tubing set allows for theuse of specialized distal portions. For example, a distal portion withan integrated pressure relief valve may be used for patient safety toguard against overpressurization of the cavity during hysteroscopy, anda distal portion without a pressure relief valve may be used forlaparoscopy. Inclusion of the pressure relief valve for laparoscopywould involve unnecessary costs and could be problematic due to higherrequired fluid pressures needed to deliver the required flow rates forlaparoscopy.

Apparatus and methods according to the present disclosure may beutilized in a wide variety of settings, such as surgical and/or otherprocedures performed on humans and/or animals, dental surgeries and/orother procedures, and/or any other medical and/or veterinary procedures,such as those involving irrigation, distention, and/or infusion.

While exemplary embodiments have been set forth above for the purpose ofdisclosure, modifications of the disclosed embodiments as well as otherembodiments thereof may occur to those skilled in the art. Accordingly,it is to be understood that the disclosure is not limited to the aboveprecise embodiments and that changes may be made without departing fromthe scope. Likewise, it is to be understood that it is not necessary tomeet any or all of the stated advantages or objects disclosed herein tofall within the scope of the disclosure, since inherent and/orunforeseen advantages of the may exist even though they may not havebeen explicitly discussed herein.

Having described the invention, the following is claimed:
 1. A fluidmanagement system comprising: a pump configured to deliver a fluid fromat least one fluid supply container to a body cavity; a remote pressuresensor configured for placement in or proximate to a body cavity; and acontrol system operatively connected to the pump and the remote pressuresensor, the control system receiving from the remote pressure sensor asignal associated with a pressure of the fluid at the location of theremote pressure sensor, and adjusting a speed of the pump to maintain adesired fluid pressure based at least in part upon the signal receivedfrom the remote pressure sensor.
 2. The fluid management system of claim1, wherein the control system receives at least one of a pneumaticsignal and an electrical signal from the remote pressure sensor.
 3. Thefluid management system of claim 1, wherein said fluid distends the bodycavity.
 4. A method for operating a fluid management system, the methodcomprising: delivering fluid from a fluid supply container to a bodycavity via a tubing set; sensing a system fluid pressure in the tubingset at a location between the fluid supply container and the bodycavity; sensing a site fluid pressure using a remote pressure sensordisposed in or proximate to a body cavity; and controlling a pressure ofthe fluid delivered to the body cavity based at least in part upon atleast one of (i) the sensed system fluid pressure and (ii) the sensedsite fluid pressure.
 5. The method of claim 4, wherein controlling thepressure of the fluid delivered to the body cavity is based at least inpart upon both (i) the sensed system fluid pressure and (ii) the sensedsite fluid pressure.
 6. The method of claim 4, wherein said fluiddelivered to the site via the tubing set distends the body cavity. 7.The method of claim 4, wherein the tubing set comprises a disposabletubing set including a pressure relief valve.